Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.
Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. (Pennsylvania): 510(k) cleared for Respironics, Inc. Its amount of 162 is above the median of 138 (59th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 48/100. 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: 162 · 59th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261262 |
| Device | Altis Full Face Mask |
| Applicant | Respironics, Inc. |
| Specialty / panel | Anesthesiology |
| Product code | BZD |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-09-25 |
| Review time (days) | 162 |
| Third-party review | No |
| Applicant location | Murrysville, PA, US |
| amount percentile | 59th of 414 (median 138, 1.2x median) |
| Peer records CSV (19 PA 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: 2026-09-25
- 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: Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.'s amount: 59th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 162-day review, longer than typical.
- Posted 41 days ago.
What is the FDAPulse record for Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. in Pennsylvania?
Altis Full Face Mask (K261262) by Respironics, Inc. was cleared on 2026-09-25 after 162 days of review.
How does Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. compare to other Pennsylvania FDAPulse records?
Its amount of 162 sits in the upper half (59th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
Altis Full Face Mask (K261262) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Altis Full Face Mask (K261262) | PA | 2026-09-25 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Helo Return (K253717) | CA | 2026-10-11 |
| Aevice Wheeze Detection Module (K260140) | SG | 2026-09-25 |
Related records
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- Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.
- Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.
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