Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KDP — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
232 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013976 | BOEHRINGER MRI SUCTION REGULATORY | Boehringer Laboratories | 2002-01-08 | 36 | 0 |
| K944479 | PM3300 INTERMITTENT VACUUM | Precision Medical, Inc. | 1994-12-22 | 100 | 0 |
| K942747 | MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) | Engineered Orthopedic Technologies, Inc. | 1994-07-21 | 41 | 0 |
| K933232 | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | Boehringer Laboratories | 1994-03-28 | 265 | 0 |
| K926140 | VACUUM POWER BODY FLUID SUCTION APPARATUS | Hill-Rom, Inc. | 1993-07-27 | 232 | 0 |
| K922817 | PM3000 & PM3100 VACUUM REGULATOR | Precision Medical, Inc. | 1993-03-04 | 266 | 0 |
| K883229 | OHMEDA CONTINUOUS SUCTION REGULATOR | Ohmeda Medical | 1988-10-19 | 79 | 0 |
| K875074 | VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 | Timeter Instrument Corp. | 1988-02-22 | 75 | 0 |
| K853155 | BOEHRINGER LAB SUCTION INTERRUPTER | Boehringer Laboratories | 1985-10-16 | 79 | 0 |
| K850200 | SUCTION REGULATOR 7700 SERIES | Boehringer Laboratories | 1985-03-04 | 45 | 0 |
| K843591 | INTERCEPT | Vital Signs, Inc. | 1984-10-19 | 37 | 0 |
| K834224 | VACUUM REGULATOR 0-2000 MMHG VR-1000 | Trimeter Instrument Corp. | 1984-02-27 | 83 | 0 |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | Sorensen Research | 1983-07-12 | 62 | 0 |
| K830343 | CONTAINER W/PRIMING SOLUTION | American Hospital Supply Corp. | 1983-03-17 | 44 | 0 |
| K821314 | FEVER METER | Steridyne Corp. | 1982-05-28 | 24 | 0 |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | Sorensen Research | 1982-04-09 | 24 | 0 |
| K820077 | EMERSON THORACIC SUCTION REG. #55-JP | J. H. Emerson Co. | 1982-01-28 | 16 | 0 |
| K801169 | OHIO FREE FLOW VACUUM REGULATOR | Ohio Medical Products | 1980-07-28 | 74 | 0 |
| K770944 | INSTATEMP | H.I. Silverman, D.Sc. | 1977-07-27 | 63 | 0 |
| K760316 | REGULATORS, LOW SUCTION | Harris-Lake, Inc. | 1976-08-04 | 9 | 0 |
| K760317 | REGULATORS, HIGH SUCTION | Harris-Lake, Inc. | 1976-08-04 | 9 | 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