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Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. vs Glucommander (K261939): 510(k) cleared for Glytec, LLC: FDAPulse comparison
Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.'s review days of 162 is 1.4x Glucommander (K261939): 510(k) cleared for Glytec, LLC's 117 (59th percentile). Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. is dated 2026-09-25; Glucommander (K261939): 510(k) cleared for Glytec, LLC 2026-10-05.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. compare to Glucommander (K261939): 510(k) cleared for Glytec, LLC?
| Field | Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. | Glucommander (K261939): 510(k) cleared for Glytec, LLC |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K261262 | K261939 |
| Device | Altis Full Face Mask | Glucommander |
| Applicant | Respironics, Inc. | Glytec, LLC |
| Specialty / panel | Anesthesiology | Anesthesiology |
| Product code | BZD | NDC |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-04-16 | 2026-06-10 |
| Decision date | 2026-09-25 | 2026-10-05 |
| Review time (days) | 162 | 117 |
| Third-party review | No | No |
| Applicant location | Murrysville, PA, US | Greenville, SC, US |
| amount percentile | 59th | 43rd |
| Predicate Speed & CAPA Advisory Opportunity Score | 48/100 | 36/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. · Glucommander (K261939): 510(k) cleared for Glytec, LLC
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