FDA product code BTK: Strap, Head, Gas Mask
BTK is the FDA product code for strap, head, gas mask. It is a Class I device, regulated under 21 CFR 868.5560 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under BTK, from 5 different applicants. The average 510(k) review took 61 days (median 39).
Classification
| Field | Value |
|---|---|
| Device name | Strap, Head, Gas Mask |
| Device class | Class I |
| Regulation | 21 CFR 868.5560 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BTK clearance
Top BTK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vital Signs, Inc. | 2 | 1994-11-14 |
| Life Design Systems, Inc. | 1 | 1985-12-03 |
| Medipart Jerry Alexander | 1 | 1985-10-29 |
| Medovations, Inc. | 1 | 1983-05-09 |
| Respironics, Inc. | 1 | 1981-04-29 |
Most recent BTK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944949 | Vital Signs, Inc. | GENERAL ANESTHESIA SYSTEM | 1994-11-14 | 38 |
| K914335 | Vital Signs, Inc. | STRAP, HEAD, GAS MASK | 1992-04-02 | 188 |
| K854537 | Life Design Systems, Inc. | HEADSTRAP | 1985-12-03 | 20 |
| K853573 | Medipart Jerry Alexander | MEDIPART FACE MASK HEADSTRAP MP-9100 | 1985-10-29 | 64 |
| K831008 | Medovations, Inc. | HEAD STRAP | 1983-05-09 | 40 |
Recalls for BTK devices
openFDA lists no recalls for product code BTK.
Frequently asked questions
What is FDA product code BTK?
BTK is the FDA product code for strap, head, gas mask. It is a Class I device, regulated under 21 CFR 868.5560 and reviewed by the Anesthesiology panel.
What device class is BTK?
Class I, regulation 21 CFR 868.5560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BTK?
Across 6 cleared submissions the average was 61 days from receipt to decision (median 39).
Which companies have the most BTK clearances?
Vital Signs, Inc. (2); Life Design Systems, Inc. (1); Medipart Jerry Alexander (1); Medovations, Inc. (1); Respironics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BTK
- Run a recall and safety report across every BTK manufacturer
- Watch product code BTK 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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