North Coast Medi-Tek: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “North Coast Medi-Tek” (first 1985, latest 1987), across 6 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 | 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent North Coast Medi-Tek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870419 | IVR-SP CUSTOM ANGIOGRAPHY TRAY | DQO | 1987-05-11 | 97 |
| K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY | GBZ | 1987-04-14 | 70 |
| K870416 | LP EXTENSION SETS | FPK | 1987-04-06 | 62 |
| K870418 | MYA-1 AND MYT-1 MYELOGRAM TRAY | — | 1987-03-17 | 42 |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | FSM | 1987-03-05 | 30 |
| K854095 | BIOPSY TRAY I & II | LRO | 1985-11-25 | 49 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2011-05-13.
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 Instrument Corp. (28 510(k)s)
- 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 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 Coast Medi-Tek?
FDA lists 6 510(k) clearances under the applicant name “North Coast Medi-Tek” (first 1985, latest 1987), across 6 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 North Coast Medi-Tek?
The median time from FDA receipt to decision across 510(k)s cleared under the name North Coast Medi-Tek is 56 days.
Which FDA product codes appear under North Coast Medi-Tek?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 1); FPK (Tubing, Fluid Delivery, 1); FSM (Tray, Surgical, Instrument, 1).
Next steps
- See all 6 North Coast Medi-Tek clearances with predicates and recalls
- Run predicate analysis for product code DQO, North Coast Medi-Tek'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.