JAY
19 FDA 510(k) clearances · Product code
31 daysmedian time to decision
107 days90th percentile
19clearances measured
FDA profile
- Official device name
- Support, Breathing Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5280
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2003: 2 · 2006: 2 · 2012: 20 · 2019: 26 · 2020: 25 · 2021: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CUSTOM MEDICAL SUSPENSION STRAP (K944988) | Custom Medical Specialties, Inc. | 1995-01-27 |
| BLOCK, BITE, INTUBATION (K873491) | B&B Medical Technologies, Inc. | 1987-10-20 |
| DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 (K860583) | Dale Medical Products, Inc. | 1986-02-21 |
| JEE FRAME (VENTILATOR CIRCUIT SUPPORT) (K850924) | Vulcan Laboratories, Inc. | 1985-07-19 |
| COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (K850309) | Ackrad Laboratories | 1985-02-14 |
| ENDO-SECURE (K840844) | Exidyne, Inc. | 1984-03-16 |
| TRACH MATE (K834265) | Tempe Biomedical, Inc. | 1984-01-04 |
| COMFIT (K834089) | Ackrad Laboratories | 1983-12-29 |
| TUBE-TITLE (K833361) | Sontek Industries, Inc. | 1983-11-03 |
| BITE-BLOCK (K833374) | Sontek Industries, Inc. | 1983-11-03 |
| SCHULTZ ENDHOLD (K833332) | Polyclinic Medical Center | 1983-10-31 |
| DALE ENDOTRACHEAL TUBE HOLDER (K832946) | Dale Medical Products, Inc. | 1983-10-14 |
| ENDOTRACHEAL TUBE HOLDER (K802675) | Respiratory Support Products, Inc. | 1980-11-19 |
| ADJUSTABLE TUBE TREE FOR ANESTH. HOSES (K792148) | Medical Innovations Corp. | 1979-11-15 |
| TUBE-STRAP (K791781) | Olympic Medical Corp. | 1979-09-19 |
| ADULT ZEE-FRAME (K790410) | Equilibrated Bio Systems, Inc. | 1979-03-22 |
| ZEE-FRAME (K781509) | Equilibrated Bio Systems, Inc. | 1978-09-26 |
| FLEX ARM BE 122, CLAMP 122-27 (K770631) | Instrumentation Industries, Inc. | 1977-05-23 |
| CLAMP BE-152 (K770628) | Instrumentation Industries, Inc. | 1977-05-23 |
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Every clearance here is in the API, with alerts when new ones post.