Concept, Inc.: FDA filings under this applicant name
FDA lists 83 510(k) clearances under the applicant name “Concept, Inc.” (first 1976, latest 1992), plus 1 PMA decision, across 51 product codes in 11 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 10 | 10 |
| HRX | Arthroscope | 10 | 10 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| HNL | Probe, Lachrymal | 3 | 3 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 2 | 2 |
| KGS | Retention Device, Suture | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
Plus 41 more product codes.
Review panels
- General and Plastic Surgery (25)
- Orthopedic (22)
- Ophthalmic (9)
- Gastroenterology and Urology (5)
- Cardiovascular (4)
- General Hospital (4)
- Anesthesiology (3)
- Ear, Nose and Throat (2)
- Dental (1)
- Neurology (1)
- Physical Medicine (1)
Most recent Concept, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | HWC | 1992-05-01 | 322 |
| K912957 | CONCEPT MICROMILL | HRX | 1991-10-04 | 88 |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | HSX | 1990-06-05 | 193 |
| K894929 | STAPLE FIXATION SYSTEM | JDR | 1989-08-30 | 28 |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | HRX | 1989-08-01 | 118 |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | KNT | 1989-05-08 | 67 |
| K881954 | CONCEPT POWER SYSTEM | HSZ | 1988-11-09 | 183 |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | ILO | 1988-11-08 | 28 |
| K882121 | C-FLO SUCTION TUBE | DXQ | 1988-06-20 | 32 |
| K880414 | TENDON HARVESTER | HRX | 1988-03-25 | 53 |
73 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P770005 | PMA | HUNTER-SESSIONS VENA-CAVA OCCLUDER | 1977-12-19 |
Recalls
openFDA lists no recalls under a recalling firm named Concept, 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.
- Concept Rubber Products Sdn Bhd (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Concept, Inc.?
FDA lists 83 510(k) clearances under the applicant name “Concept, Inc.” (first 1976, latest 1992), plus 1 PMA decision, across 51 product codes in 11 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 Concept, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Concept, Inc. is 38 days.
Which FDA product codes appear under Concept, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 10); HRX (Arthroscope, 10); HWC (Screw, Fixation, Bone, 4).
Next steps
- See all 83 Concept, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Concept, 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.