FDA product code JAY: Support, Breathing Tube
JAY is the FDA product code for support, breathing tube. It is a Class I device, regulated under 21 CFR 868.5280 and reviewed by the Anesthesiology panel. FDA has cleared 19 510(k) submissions under JAY, from 14 different applicants. The average 510(k) review took 39 days (median 31). FDA has posted 2 recalls for JAY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Support, Breathing Tube |
| Device class | Class I |
| Regulation | 21 CFR 868.5280 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JAY clearance
Top JAY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dale Medical Products, Inc. | 2 | 1986-02-21 |
| Ackrad Laboratories | 2 | 1985-02-14 |
| Sontek Industries, Inc. | 2 | 1983-11-03 |
| Equilibrated Bio Systems, Inc. | 2 | 1979-03-22 |
| Instrumentation Industries, Inc. | 2 | 1977-05-23 |
9 more applicants have JAY clearances. See the full list in Caduvo.
Most recent JAY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944988 | Custom Medical Specialties, Inc. | CUSTOM MEDICAL SUSPENSION STRAP | 1995-01-27 | 107 |
| K873491 | B&B Medical Technologies, Inc. | BLOCK, BITE, INTUBATION | 1987-10-20 | 50 |
| K860583 | Dale Medical Products, Inc. | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | 1986-02-21 | 3 |
| K850924 | Vulcan Laboratories, Inc. | JEE FRAME (VENTILATOR CIRCUIT SUPPORT) | 1985-07-19 | 136 |
| K850309 | Ackrad Laboratories | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK | 1985-02-14 | 20 |
Recalls for JAY devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-20.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code JAY?
JAY is the FDA product code for support, breathing tube. It is a Class I device, regulated under 21 CFR 868.5280 and reviewed by the Anesthesiology panel.
What device class is JAY?
Class I, regulation 21 CFR 868.5280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JAY?
Across 19 cleared submissions the average was 39 days from receipt to decision (median 31).
Which companies have the most JAY clearances?
Dale Medical Products, Inc. (2); Ackrad Laboratories (2); Sontek Industries, Inc. (2); Equilibrated Bio Systems, Inc. (2); Instrumentation Industries, Inc. (2).
Have JAY devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-10-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JAY
- Run a recall and safety report across every JAY manufacturer
- Watch product code JAY 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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