FDA product code KGB: Mask, Oxygen, Non-Rebreathing
KGB is the FDA product code for mask, oxygen, non-rebreathing. It is a Class I device, regulated under 21 CFR 868.5570 and reviewed by the Anesthesiology panel. FDA has cleared 13 510(k) submissions under KGB, from 11 different applicants. The average 510(k) review took 143 days (median 164). FDA has posted 8 recalls for KGB devices.
Classification
| Field | Value |
|---|---|
| Device name | Mask, Oxygen, Non-Rebreathing |
| Device class | Class I |
| Regulation | 21 CFR 868.5570 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KGB clearance
Top KGB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hans Rudolph, Inc. | 2 | 1996-06-20 |
| Airlife, Inc. | 2 | 1979-04-20 |
| Cheen Houng Ent. Co. , Ltd. | 1 | 1997-09-26 |
| Gam Industries, Inc. | 1 | 1994-09-09 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1994-02-04 |
6 more applicants have KGB clearances. See the full list in Caduvo.
Most recent KGB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970688 | Cheen Houng Ent. Co. , Ltd. | POCKET RESCUE | 1997-09-26 | 213 |
| K960401 | Hans Rudolph, Inc. | ULTIMATE SEAL | 1996-06-20 | 143 |
| K941336 | Gam Industries, Inc. | COMBO MASK | 1994-09-09 | 172 |
| K935917 | Bd Becton Dickinson Vacutainer Systems Preanalytic | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | 1994-02-04 | 56 |
| K932347 | Vital Signs, Inc. | COMPACT MASK | 1994-01-10 | 241 |
Recalls for KGB devices
8 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-11-11.
| Year | Recalls |
|---|---|
| 2020 | 6 |
Frequently asked questions
What is FDA product code KGB?
KGB is the FDA product code for mask, oxygen, non-rebreathing. It is a Class I device, regulated under 21 CFR 868.5570 and reviewed by the Anesthesiology panel.
What device class is KGB?
Class I, regulation 21 CFR 868.5570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGB?
Across 13 cleared submissions the average was 143 days from receipt to decision (median 164).
Which companies have the most KGB clearances?
Hans Rudolph, Inc. (2); Airlife, Inc. (2); Cheen Houng Ent. Co. , Ltd. (1); Gam Industries, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Have KGB devices been recalled?
Yes: 8 product recalls across 2 recall events; the most recent began 2020-11-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KGB
- Run a recall and safety report across every KGB manufacturer
- Watch product code KGB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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