Impact Instrumentation, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Impact Instrumentation, Inc.” (first 1981, latest 2014), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 265 |
| 2013 | 0 | — |
| 2014 | 1 | 144 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 5 | 5 |
| CBK | Ventilator, Continuous, Facility Use | 5 | 5 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 5 | 5 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 3 | 3 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| FOX | Stand, Infusion | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Impact Instrumentation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133196 | IMPACT MODEL 323 ASPIRATOR | JCX | 2014-03-10 | 144 |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR | CBK | 2012-02-16 | 265 |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR | CBK | 2011-04-07 | 146 |
| K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ | CBK | 2009-08-13 | 108 |
| K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV | CBK | 2008-12-10 | 555 |
| K051476 | UNI-VENT MODEL 73X | BTL | 2005-10-28 | 147 |
| K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | BTL | 2004-03-26 | 235 |
| K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | MOD | 2003-05-06 | 315 |
| K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT | BTA | 1995-04-18 | 22 |
| K941096 | ELECTRIC VACUM PUMP | BTA | 1995-01-05 | 304 |
17 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2012-03-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Impact Applications, Inc. (5 510(k)s)
- Impact Case Technologies, Inc. (1 510(k)s)
- Impact Medical, LLC (1 510(k)s)
- Impact Monitors, Inc. (1 510(k)s)
- Impact Packaging Corp. (1 510(k)s)
- Impact Systems Corp. (1 510(k)s)
- Impact Wheelchair Manufacture, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Impact Instrumentation, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Impact Instrumentation, Inc.” (first 1981, latest 2014), across 11 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Impact Instrumentation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Impact Instrumentation, Inc. is 56 days.
Which FDA product codes appear under Impact Instrumentation, Inc.?
The most frequent FDA product codes under this applicant name are BTL (Ventilator, Emergency, Powered (Resuscitator), 5); CBK (Ventilator, Continuous, Facility Use, 5); JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 5).
Next steps
- See all 27 Impact Instrumentation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTL, Impact Instrumentation, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.