Contour Fabricators, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Contour Fabricators, Inc.” (first 1979, latest 2009), across 8 product codes in 3 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| MMP | Cover, Barrier, Protective | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
Most recent Contour Fabricators, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090773 | CFI ULTRASOUND PROBE DRAPE | IYO | 2009-09-18 | 179 |
| K970900 | INSTRUMENT HOLDER | GCJ | 1997-05-22 | 72 |
| K971040 | CABLE HOLDER, SUCTION TUBE HOLDER | GEI | 1997-04-16 | 26 |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | KKX | 1997-04-10 | 83 |
| K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER | MOS | 1997-01-30 | 107 |
| K963453 | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) | FMQ | 1996-11-15 | 73 |
| K820692 | BANDBAG, WRAP, STERILE | MMP | 1982-05-03 | 52 |
| K782155 | GENERAL EQUIPMENT COVER | IZL | 1979-01-17 | 26 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-09-09.
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 Contour Fabricators, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
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 Medical Technology, Inc. (9 510(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 Fabricators, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Contour Fabricators, Inc.” (first 1979, latest 2009), across 8 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 Contour Fabricators, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contour Fabricators, Inc. is 72 days.
Which FDA product codes appear under Contour Fabricators, Inc.?
The most frequent FDA product codes under this applicant name are FMQ (Restraint, Protective, 1); GCJ (Laparoscope, General & Plastic Surgery, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 8 Contour Fabricators, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Contour Fabricators, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.