Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BYH — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
39 daysmedian FDA review time
110 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946057 | AQUALARM MOISTURE SENSOR MODEL P85000 | Pegasus Research Corp. | 1995-05-05 | 144 | 0 |
| K932722 | CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM | Carie Med-Tech Services, Inc. | 1993-08-06 | 63 | 0 |
| K921624 | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS | Intertech Resources, Inc. | 1992-06-30 | 85 | 0 |
| K900047 | THAYER SUCTION EVACUATION CONDENSATE COLLECTION | Thayer Medical Corp. | 1990-04-23 | 110 | 0 |
| K897057 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | 1990-03-16 | 88 | 0 |
| K895479 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | 1990-03-09 | 179 | 0 |
| K900591 | VENT-TRAP CAT# WR1000 | Ventlab Corp. | 1990-03-09 | 30 | 0 |
| K885088 | THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | 1989-01-12 | 31 | 0 |
| K882739 | INTERTECH LARGE VOLUME WATER TRAP (LVW) | Intertech Resources, Inc. | 1988-08-09 | 39 | 0 |
| K881790 | SAFETY DRAIN | Ballard Medical Products | 1988-06-21 | 56 | 0 |
| K873447 | DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR | Dhd Medical Products Div. Diemolding Corp. | 1987-10-30 | 74 | 0 |
| K864147 | AQUAVALVE | Respiratory Care, Inc. | 1986-12-05 | 44 | 0 |
| K860884 | SELF-SEALING WATER TRAP/ACCESSORIES | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K860883 | SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K853665 | SPLASH ADAPTOR | Ohio Medical Research, Inc. | 1985-10-10 | 37 | 0 |
| K834573 | AQUA TRAP | Airlife, Inc. | 1984-03-05 | 67 | 0 |
| K820936 | MOISTURE TRAP | Dhd Medical Products Div. Diemolding Corp. | 1982-04-29 | 27 | 0 |
| K812569 | SHERWOOD WATER TRAP | Sherwood Medical Co. | 1981-09-25 | 16 | 0 |
| K800990 | TRACH MIST UNIT W/OR WITHOUT ELBOW | Airlife, Inc. | 1980-05-08 | 14 | 0 |
| K792390 | MOISTURE TRAP | Dhd Medical Products Div. Diemolding Corp. | 1979-12-04 | 8 | 0 |
| K790929 | DRAINAGE BAG | Mem Medical, Inc. | 1979-05-21 | 6 | 0 |
| K770771 | AEROSOL EFFUSION SYSTEM #1740 | Hudson Oxygen Therapy Sales Co. | 1977-06-02 | 35 | 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