BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics
BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics (Utah): 510(k) cleared for Biofire Diagnostics. Its amount of 21 is below the median of 138 (1st percentile). Dated 43 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-04, 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: 21 · 1th percentile of 414 FDAPulse records · 0.2x 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 | K263054 |
| Device | BIOFIRE Respiratory Panel 2.1 (RP2.1) |
| Applicant | Biofire Diagnostics |
| Specialty / panel | Microbiology |
| Product code | QOF |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-01 |
| Decision date | 2026-09-22 |
| Review time (days) | 21 |
| Third-party review | No |
| Applicant location | Salt Lake City, UT, US |
| amount percentile | 1th of 414 (median 138, 0.2x median) |
| Peer records CSV (11 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-09-22
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics and 11 Utah peers
- Utah FDAPulse records like this one: 11
- BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics's amount: 1st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 21-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 43 days ago.
What is the FDAPulse record for BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics in Utah?
BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054) by Biofire Diagnostics was cleared on 2026-09-22 after 21 days of review.
How does BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics compare to other Utah FDAPulse records?
Its amount of 21 is below the median (1th percentile); smaller records often move faster and face less competition. It is 43 days old, still within a typical 45-day follow-up window.
BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054) | UT | 2026-09-22 |
| 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.
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- Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid
- Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®
- BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC
- SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.
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