Instrumentation Industries, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Instrumentation Industries, Inc.” (first 1977, latest 2019), plus 1 PMA decision, across 24 product codes in 6 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 | 45 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 151 |
| 2018 | 0 | — |
| 2019 | 1 | 428 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Instrumentation Industries, Inc. took a median 290 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | 7 | 7 |
| CAF | Nebulizer (Direct Patient Interface) | 6 | 6 |
| BSK | Cuff, Tracheal Tube, Inflatable | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 3 | 3 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 2 | 2 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| CAN | Regulator, Pressure, Gas Cylinder | 2 | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| JAY | Support, Breathing Tube | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
Plus 14 more product codes.
Review panels
- Anesthesiology (40)
- Radiology (2)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Instrumentation Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | CAP | 2019-05-01 | 428 |
| K162753 | RTC 26-C Inline Aerosol Adapter | CAF | 2017-02-28 | 151 |
| K113644 | PILOT TUBE REPAIR KIT | BSK | 2012-01-26 | 45 |
| K102127 | ENDOTRACHEAL TUBE CHANGERS | LNZ | 2010-08-27 | 29 |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | CAF | 2010-07-22 | 20 |
| K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC | CAF | 2009-12-02 | 229 |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | CAP | 2008-09-12 | 81 |
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | BXR | 2008-09-11 | 86 |
| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | CAF | 2000-01-27 | 283 |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | CBK | 1999-09-17 | 88 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800068 | PMA | ENDOTRACHEAL TUBE CHANGER | 1981-07-21 |
Recalls
7 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2015-09-23.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Instrumentation Industries, Inc. (a text match, not an official crosswalk):
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.
- Instrumentation Laboratory CO (323 510(k)s)
- Instrumentation Laboratory (IL) Co. (5 510(k)s)
- Instrumentation Laboratory Company (3 510(k)s)
- Instrumentation Camera, Inc. (2 510(k)s)
- Instrumentation Specialties, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instrumentation Industries, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Instrumentation Industries, Inc.” (first 1977, latest 2019), plus 1 PMA decision, across 24 product codes in 6 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 Instrumentation Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instrumentation Industries, Inc. is 56 days.
Which FDA product codes appear under Instrumentation Industries, Inc.?
The most frequent FDA product codes under this applicant name are CBP (Valve, Non-Rebreathing, 7); CAF (Nebulizer (Direct Patient Interface), 6); BSK (Cuff, Tracheal Tube, Inflatable, 3).
Next steps
- See all 45 Instrumentation Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBP, Instrumentation Industries, 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.