Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ventlab Corp. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
309 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | Ventlab Corp. | 2012-05-24 | 128 | 0 |
| K102674 | CUFF SENTRY | Ventlab Corp. | 2011-07-22 | 309 | 0 |
| K093617 | VENTLAB 6000 SERIES HUMIDIFIER | Ventlab Corp. | 2011-01-27 | 430 | 0 |
| K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICAT | Ventlab Corp. | 2009-12-10 | 24 | 1 |
| K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CU | Ventlab Corp. | 2009-06-25 | 90 | 0 |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | Ventlab Corp. | 2008-08-13 | 8 | 0 |
| K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | Ventlab Corp. | 2008-03-26 | 460 | 0 |
| K040726 | VENTLAB NASAL CPAP CANNULA | Ventlab Corp. | 2004-06-03 | 73 | 0 |
| K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | Ventlab Corp. | 2003-07-07 | 161 | 0 |
| K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | 2002-02-11 | 14 | 0 |
| K013308 | VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | 2001-12-20 | 77 | 0 |
| K012842 | V*CARE MANUAL RESUSCITATOR | Ventlab Corp. | 2001-09-18 | 26 | 21 |
| K990098 | VENTLAB VERIFY II | Ventlab Corp. | 1999-02-11 | 30 | 0 |
| K981944 | BREATHERITE | Ventlab Corp. | 1998-08-24 | 82 | 0 |
| K913900 | V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 | Ventlab Corp. | 1992-01-07 | 130 | 0 |
| K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | Ventlab Corp. | 1990-09-04 | 13 | 0 |
| K900591 | VENT-TRAP CAT# WR1000 | Ventlab Corp. | 1990-03-09 | 30 | 0 |
| K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | Ventlab Corp. | 1990-02-22 | 44 | 0 |
| K900236 | ET-RESTRAINT CAT. # ER 4000 | Ventlab Corp. | 1990-02-02 | 16 | 0 |
| K896897 | VENTLAB ANESTHESIA CIRCUIT AC 6000 | Ventlab Corp. | 1990-01-26 | 49 | 0 |
| K896439 | TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE | Ventlab Corp. | 1990-01-09 | 61 | 0 |
| K890822 | CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) | Ventlab Corp. | 1989-05-05 | 77 | 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