Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Omni Medical, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
272 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922781 | FLOW CONROL VALVE | American Omni Medical, Inc. | 1993-03-08 | 272 | 0 |
| K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 | American Omni Medical, Inc. | 1993-02-12 | 269 | 0 |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | 1990-04-03 | 49 | 0 |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | American Omni Medical, Inc. | 1989-01-30 | 69 | 0 |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | American Omni Medical, Inc. | 1989-01-24 | 78 | 0 |
| K873316 | BUBBLE TRAP-FILTER CAT. NO B180F37 | American Omni Medical, Inc. | 1988-07-14 | 330 | 0 |
| K875080 | AIR VENT LINE CAT. NO. AVL-36 | American Omni Medical, Inc. | 1988-02-29 | 82 | 0 |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | American Omni Medical, Inc. | 1987-11-06 | 49 | 0 |
| K873610 | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 | American Omni Medical, Inc. | 1987-11-05 | 58 | 0 |
| K873488 | SILENT GUARD CAT. NO. SG-10 | American Omni Medical, Inc. | 1987-10-07 | 37 | 0 |
| K871632 | NASOGASTRIC VOICETUBE | American Omni Medical, Inc. | 1987-09-16 | 142 | 0 |
| K870819 | BUBBLE TRAP CAT. NO. B-180 | American Omni Medical, Inc. | 1987-06-08 | 97 | 0 |
| K871350 | PREBYPASS FILTER | American Omni Medical, Inc. | 1987-06-08 | 63 | 0 |
| K864503 | MODIFIED RLV-2100 B | American Omni Medical, Inc. | 1987-01-06 | 53 | 0 |
| K862950 | WHITE-SIPOSS TUBE, CAT NO WS-1 | American Omni Medical, Inc. | 1986-10-30 | 86 | 0 |
| K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | American Omni Medical, Inc. | 1986-06-26 | 71 | 0 |
| K852178 | EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS | American Omni Medical, Inc. | 1985-12-27 | 221 | 0 |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | 1985-10-21 | 137 | 0 |
| K851406 | AJDJUSTABLE SUCTION CONTROL VALVE | American Omni Medical, Inc. | 1985-08-05 | 118 | 0 |
| K851465 | SILENT GUARD CAT. NO. SG-30 | American Omni Medical, Inc. | 1985-08-05 | 116 | 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