OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc.
OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc. (Massachusetts): 510(k) cleared for Ironsides Medical, Inc. Its amount of 118 is below the median of 138 (44th percentile). Dated 44 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: 118 · 44th percentile of 414 FDAPulse records · 0.9x 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 | K261725 |
| Device | OtoCompanion (Version 1.0) |
| Applicant | Ironsides Medical, Inc. |
| Specialty / panel | Other |
| Product code | SHL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-26 |
| Decision date | 2026-09-21 |
| Review time (days) | 118 |
| Third-party review | No |
| Applicant location | Cambridge, MA, US |
| amount percentile | 44th of 414 (median 138, 0.9x median) |
| Peer records CSV (41 MA 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: 2026-09-21
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc.'s amount: 44th 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 118-day review: this device is a strong predicate for similar products.
- Posted 44 days ago.
What is the FDAPulse record for OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc. in Massachusetts?
OtoCompanion (Version 1.0) (K261725) by Ironsides Medical, Inc. was cleared on 2026-09-21 after 118 days of review.
How does OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc. compare to other Massachusetts FDAPulse records?
Its amount of 118 is below the median (44th percentile); smaller records often move faster and face less competition. It is 44 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.
OtoCompanion (Version 1.0) (K261725) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OtoCompanion (Version 1.0) (K261725) | MA | 2026-09-21 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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