Contour Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Contour Medical Technology, Inc.” (first 1996, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 290 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | 6 | 6 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
Review panels
- General Hospital (6)
- Cardiovascular (3)
Most recent Contour Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970391 | QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES | MKJ | 1997-03-06 | 31 |
| K970125 | NOAH MONITORING ELECTRODE SYSTEM | DRX | 1997-03-04 | 49 |
| K960329 | DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD | MKJ | 1996-07-02 | 160 |
| K952807 | TEMPERATURE PROBE-TP650 | FMT | 1996-04-04 | 290 |
| K952805 | TEMPERATURE PROBE-TP550 | FMT | 1996-04-04 | 290 |
| K952804 | TEMPERATURE PROBE-TP450 | FMT | 1996-04-04 | 290 |
| K952803 | TEMPERATURE PROBE-TP350 | FMT | 1996-04-04 | 290 |
| K952801 | TEMPERATURE PROBE-TP250 | FMT | 1996-04-04 | 290 |
| K952800 | TEMPERATURE PROBE-TP150 | FMT | 1996-04-04 | 290 |
Recalls
openFDA lists no recalls under a recalling firm named Contour Medical Technology, Inc..
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.
- Contour Fabricators of Florida, Inc. (18 510(k)s)
- Contour Fabricators, Inc. (8 510(k)s)
- Contour Electrodes, Inc. (4 510(k)s)
- Contour Research, LLC (2 510(k)s)
- Contour, Inc. (1 510(k)s)
- Contour Healer, LLC (1 510(k)s)
- Contour Medical Systems, Inc. (1 510(k)s)
- Contour Technology (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Contour Medical Technology, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Contour Medical Technology, Inc.” (first 1996, latest 1997), across 3 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 Contour Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contour Medical Technology, Inc. is 290 days.
Which FDA product codes appear under Contour Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are FMT (Warmer, Infant Radiant, 6); MKJ (Automated External Defibrillators (Non-Wearable), 2); DRX (Electrode, Electrocardiograph, 1).
Next steps
- See all 9 Contour Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMT, Contour Medical Technology, 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.