BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC
BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC (Utah): 510(k) cleared for Biofire Diagnostics, LLC. Its amount of 118 is below the median of 138 (44th percentile). Dated 14 days ago, it is in the active follow-up window. Score 42/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 118 · 44th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 10 related UT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262136 |
| Device | BIOFIRE SPOTFIRE Vaginitis (VG) Panel |
| Applicant | Biofire Diagnostics, LLC |
| Specialty / panel | Microbiology |
| Product code | PQA |
| Device class | 2 |
| Clearance type | Dual Track |
| Decision | Substantially Equivalent |
| Received | 2026-06-25 |
| Decision date | 2026-10-21 |
| Review time (days) | 118 |
| Third-party review | No |
| Applicant location | Salt Lake City, UT, US |
| amount percentile | 44th of 414 (median 138, 0.9x median) |
| Peer records CSV (11 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics + all 11 UT records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (UT first): Aristotle 65 Macrowire (K254181) · TruVision Single-Use 1.9mm Arthroscopy System (K260156) · Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® · OsteoCentric Technologies Cannulated and Soild Fasteners wit · BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC and 11 Utah peers
- Utah FDAPulse records like this one: 11
- BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC's amount: 44th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 118-day review: this device is a strong predicate for similar products.
- Posted 14 days ago.
What is the FDAPulse record for BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC in Utah?
BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136) by Biofire Diagnostics, LLC was cleared on 2026-10-21 after 118 days of review.
How does BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC compare to other Utah FDAPulse records?
Its amount of 118 is below the median (44th percentile); smaller records often move faster and face less competition. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136) | UT | 2026-10-21 |
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
Related records
- B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
- Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
- Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics
- VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.
- DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC
- Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.
- VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.
- Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid
- Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®
- SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.
- Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Microbiology devices
More Utah public-record feeds
New NIH Research Awards by Organization in Utah New, Terminating & Large 401(k) Plans from Form 5500 Filings in Utah New NSF Research Awards by Institution in Utah New SEC-Registered Investment Advisers (RIAs) with AUM & Location in Utah New Trucking Company Registrations in Utah CMS HAC Reduction & Readmissions Penalties by Hospital in Utah Bank Branch Openings, Closings & Mergers by State in Utah Carrier Out-of-Service Alerts in Utah
How to monitor BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC and peer microbiology records
Get new FDAPulse records like BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.