510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SGRClass II

Noninvasive Positive Airway Pressure System, Facility Use

21 CFR 868.5895 / Anesthesiology
FDA source (opens on fda.gov)

SGR is the FDA product code for Noninvasive Positive Airway Pressure System, Facility Use, a class II device type, regulated under 21 CFR 868.5895. FDA's definition for this code reads: "To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SGR
Device name
Noninvasive Positive Airway Pressure System, Facility Use
FDA definition
To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SGR

By decision year
2 clearances under product code SGR with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGR by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SGR
Applicants holding the most 510(k) clearances under product code SGR
ApplicantClearances
Fisher & Paykel Healthcare, Inc.1
Innaccel Technologies Private Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code