North American Instrument Corp.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “North American Instrument Corp.” (first 1983, latest 1996), across 15 product codes in 5 review panels. Median 510(k) review time under this name: 72 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 5 | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DRC | Trocar | 3 | 3 |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
Plus 5 more product codes.
Review panels
- Cardiovascular (19)
- General and Plastic Surgery (4)
- General Hospital (3)
- Gastroenterology and Urology (1)
- Radiology (1)
Most recent North American Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960801 | SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) | DQO | 1996-03-29 | 31 |
| K955554 | HEMO-VALVE | DTL | 1996-03-04 | 90 |
| K960310 | EPIC INTRODUCER SHEATH | DYB | 1996-02-07 | 16 |
| K922552 | MORSE(R) ANGIOGRAPHIC CATHETERS | DQO | 1993-03-03 | 278 |
| K915078 | MORSE HEMOSTATIC CATHETER INTRODUCER SET | DYB | 1992-06-10 | 215 |
| K905208 | MORSE ANESTHESIA | FPA | 1992-01-10 | 416 |
| K912961 | MORSE VASCULAR INTRODUCER SET | DYB | 1991-09-11 | 65 |
| K910764 | THE PERCEPTOR(TM) STAND ALONE TRANSDUCER | DRS | 1991-04-22 | 81 |
| K903493 | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM | IZI | 1991-03-26 | 235 |
| K904275 | MORSE BALLOON INFLATION DEVICE | MAV | 1991-01-03 | 107 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named North American Instrument Corp..
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.
- North American Sterilization & Packaging Co. (16 510(k)s)
- North American Philips Corp. (15 510(k)s)
- North Pacific Dental, Inc. (11 510(k)s)
- North East Monitoring, Inc. (10 510(k)s)
- North American Technical Services Corp. (9 510(k)s)
- North American Biologicals, Inc. (6 510(k)s)
- North American Medical Products, Inc. (6 510(k)s)
- North American Science Assoc., Inc. (6 510(k)s)
- North Coast Medi-Tek (6 510(k)s)
- North American Alloys, Inc. (5 510(k)s)
- North American Scientific, Inc. (4 510(k)s)
- North Eos Industries, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under North American Instrument Corp.?
FDA lists 28 510(k) clearances under the applicant name “North American Instrument Corp.” (first 1983, latest 1996), across 15 product codes in 5 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 North American Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name North American Instrument Corp. is 72 days.
Which FDA product codes appear under North American Instrument Corp.?
The most frequent FDA product codes under this applicant name are DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 5); DQO (Catheter, Intravascular, Diagnostic, 3); DRC (Trocar, 3).
Next steps
- See all 28 North American Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code DTL, North American Instrument Corp.'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.