Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAY — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
107 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944988 | CUSTOM MEDICAL SUSPENSION STRAP | Custom Medical Specialties, Inc. | 1995-01-27 | 107 | 0 |
| K873491 | BLOCK, BITE, INTUBATION | B&B Medical Technologies, Inc. | 1987-10-20 | 50 | 0 |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Dale Medical Products, Inc. | 1986-02-21 | 3 | 0 |
| K850924 | JEE FRAME (VENTILATOR CIRCUIT SUPPORT) | Vulcan Laboratories, Inc. | 1985-07-19 | 136 | 0 |
| K850309 | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK | Ackrad Laboratories | 1985-02-14 | 20 | 0 |
| K840844 | ENDO-SECURE | Exidyne, Inc. | 1984-03-16 | 21 | 0 |
| K834265 | TRACH MATE | Tempe Biomedical, Inc. | 1984-01-04 | 27 | 0 |
| K834089 | COMFIT | Ackrad Laboratories | 1983-12-29 | 31 | 0 |
| K833361 | TUBE-TITLE | Sontek Industries, Inc. | 1983-11-03 | 37 | 0 |
| K833374 | BITE-BLOCK | Sontek Industries, Inc. | 1983-11-03 | 37 | 0 |
| K833332 | SCHULTZ ENDHOLD | Polyclinic Medical Center | 1983-10-31 | 34 | 0 |
| K832946 | DALE ENDOTRACHEAL TUBE HOLDER | Dale Medical Products, Inc. | 1983-10-14 | 42 | 0 |
| K802675 | ENDOTRACHEAL TUBE HOLDER | Respiratory Support Products, Inc. | 1980-11-19 | 21 | 0 |
| K792148 | ADJUSTABLE TUBE TREE FOR ANESTH. HOSES | Medical Innovations Corp. | 1979-11-15 | 24 | 0 |
| K791781 | TUBE-STRAP | Olympic Medical Corp. | 1979-09-19 | 8 | 0 |
| K790410 | ADULT ZEE-FRAME | Equilibrated Bio Systems, Inc. | 1979-03-22 | 24 | 0 |
| K781509 | ZEE-FRAME | Equilibrated Bio Systems, Inc. | 1978-09-26 | 25 | 0 |
| K770631 | FLEX ARM BE 122, CLAMP 122-27 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770628 | CLAMP BE-152 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda