Coast Medical Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Coast Medical Corp.” (first 1992, latest 1995), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 3 | 3 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
Review panels
- Anesthesiology (8)
- General Hospital (3)
Most recent Coast Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952243 | EXTENSION SET/I.V. SET | FPK | 1995-07-26 | 75 |
| K930929 | ESOPHAGEAL STETHOSCOPE | BZT | 1995-03-17 | 752 |
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE | BSR | 1994-12-21 | 86 |
| K943270 | SURFACE TEMPERATURE PROBES | FLL | 1994-12-05 | 151 |
| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | BZT | 1994-09-08 | 51 |
| K943110 | GAS SAMPLING INTERFACES | BYX | 1994-08-19 | 51 |
| K930930 | COAST MEDICAL, INC. RECTAL PROBE | FLL | 1994-02-25 | 367 |
| K925781 | DISPOSABLE CUFFED ENDOTRACHEAL TUBE | BTR | 1993-04-19 | 158 |
| K925855 | DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE | BTR | 1993-02-18 | 93 |
| K921077 | DISPOSABLE INTUBATION KITS | BTR | 1992-08-25 | 176 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coast Medical 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.
- Coast Hearing Services (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coast Medical Corp.?
FDA lists 11 510(k) clearances under the applicant name “Coast Medical Corp.” (first 1992, latest 1995), across 7 product codes in 2 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 Coast Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coast Medical Corp. is 93 days.
Which FDA product codes appear under Coast Medical Corp.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 3); BZT (Stethoscope, Esophageal, With Electrical Conductors, 2); FLL (Continuous Measurement Thermometer, 2).
Next steps
- See all 11 Coast Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Coast Medical 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.