Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Impact Instrumentation, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
322 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133196 | IMPACT MODEL 323 ASPIRATOR | Impact Instrumentation, Inc. | 2014-03-10 | 144 | 0 |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILA | Impact Instrumentation, Inc. | 2012-02-16 | 265 | 1 |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTIL | Impact Instrumentation, Inc. | 2011-04-07 | 146 | 1 |
| K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ | Impact Instrumentation, Inc. | 2009-08-13 | 108 | 0 |
| K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV | Impact Instrumentation, Inc. | 2008-12-10 | 555 | 0 |
| K051476 | UNI-VENT MODEL 73X | Impact Instrumentation, Inc. | 2005-10-28 | 147 | 0 |
| K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | Impact Instrumentation, Inc. | 2004-03-26 | 235 | 0 |
| K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820 | Impact Instrumentation, Inc. | 2003-05-06 | 315 | 0 |
| K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT | Impact Instrumentation, Inc. | 1995-04-18 | 22 | 0 |
| K941096 | ELECTRIC VACUM PUMP | Impact Instrumentation, Inc. | 1995-01-05 | 304 | 0 |
| K931473 | IMPACT MODEL 753 | Impact Instrumentation, Inc. | 1994-12-30 | 646 | 0 |
| K905697 | POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE | Impact Instrumentation, Inc. | 1990-12-27 | 3 | 0 |
| K870861 | UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR | Impact Instrumentation, Inc. | 1988-01-19 | 322 | 0 |
| K861272 | IMPACT MODELS 701, 702 AND 703 | Impact Instrumentation, Inc. | 1986-05-20 | 46 | 0 |
| K851611 | IMPACT TURBO CATH | Impact Instrumentation, Inc. | 1985-06-05 | 57 | 0 |
| K850671 | IMPACT 901 SERIES PORT-A-WALL | Impact Instrumentation, Inc. | 1985-03-11 | 19 | 0 |
| K842050 | IMPACT MODEL 316 | Impact Instrumentation, Inc. | 1984-08-03 | 73 | 0 |
| K841538 | IMPACT MODEL 308 | Impact Instrumentation, Inc. | 1984-06-11 | 56 | 0 |
| K841537 | IMPACT MODEL 601 | Impact Instrumentation, Inc. | 1984-05-31 | 45 | 0 |
| K820424 | IMPACT, MODEL 310 | Impact Instrumentation, Inc. | 1982-03-12 | 24 | 0 |
| K820337 | IMPACT, MODEL 303 | Impact Instrumentation, Inc. | 1982-03-02 | 22 | 0 |
| K820338 | IMPACT, MODELS 306/307 | Impact Instrumentation, Inc. | 1982-03-02 | 22 | 0 |
| K820331 | IMPACT, MODEL 302 | Impact Instrumentation, Inc. | 1982-02-23 | 15 | 1 |
| K820330 | IMPACT, MODEL E-12 | Impact Instrumentation, Inc. | 1982-02-23 | 15 | 0 |
| K811014 | RESPIRATORY SENSOR | Impact Instrumentation, Inc. | 1981-06-02 | 48 | 0 |
| K811265 | RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) | Impact Instrumentation, Inc. | 1981-06-02 | 21 | 0 |
| K810753 | AIRWAY PRESSURE MONITOR | Impact Instrumentation, Inc. | 1981-03-31 | 11 | 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