BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc.
BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc. (Massachusetts): 510(k) cleared for BTL Industries, Inc. Its amount of 75 is below the median of 138 (20th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 36/100. 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: 75 · 20th percentile of 414 FDAPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262353 |
| Device | BTL-299-F |
| Applicant | BTL Industries, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | KPI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-10 |
| Decision date | 2026-09-23 |
| Review time (days) | 75 |
| Third-party review | No |
| Applicant location | Marlborough, MA, US |
| amount percentile | 20th of 414 (median 138, 0.5x median) |
| Peer records CSV (41 MA records) | 🔒 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: 2026-09-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (MA first): GSPE Spacer (K260063) · Sensinel Cardiopulmonary Management (CPM) System (K260801) · multiFiltratePRO System (K261203) · a2z-Abdo-Triage (K260906) · BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) · 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
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Peer benchmark and outreach value: BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc.'s amount: 20th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 75-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc. in Massachusetts?
BTL-299-F (K262353) by BTL Industries, Inc. was cleared on 2026-09-23 after 75 days of review.
How does BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc. compare to other Massachusetts FDAPulse records?
Its amount of 75 is below the median (20th percentile); smaller records often move faster and face less competition. It is 42 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
BTL-299-F (K262353) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BTL-299-F (K262353) | MA | 2026-09-23 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
Related records
- CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.
- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
- colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG
- Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin
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