Medical Device Inspection Co., Inc.: FDA clearances and approvals
Medical Device Inspection Co., Inc. has 30 FDA 510(k) clearances (first 1990, latest 1995), across 20 product codes in 7 review panels. Median 510(k) review time: 106 days.
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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 4 | 4 |
| INQ | Table, Powered | 4 | 4 |
| EMA | Cement, Dental | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| MCY | Wound Dressing Kit | 2 | 2 |
| BYZ | Trap, Sterile Specimen | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
Plus 10 more product codes.
Review panels
- General and Plastic Surgery (10)
- Physical Medicine (6)
- General Hospital (5)
- Obstetrics and Gynecology (4)
- Dental (3)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Medical Device Inspection Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945826 | J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS | HCC | 1995-08-04 | 248 |
| K932072 | JARIT SURGICAL INSTRUMENTS | HET | 1994-01-11 | 258 |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | IOQ | 1993-12-21 | 265 |
| K933581 | POWERMATIC TREATMENT TABLE | INQ | 1993-11-05 | 106 |
| K933580 | POWER WORK TABLE | INQ | 1993-11-05 | 106 |
| K933578 | POWERMATIC MAT PLATFORM | INQ | 1993-11-05 | 106 |
| K933577 | POWERMATIC EXAMINATION TABLE | INQ | 1993-09-30 | 70 |
| K922045 | SHOWER CHAIRS | INM | 1992-05-26 | 25 |
| K912075 | C-SECTION TRAY | KNA | 1992-04-07 | 333 |
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY | LRO | 1992-02-24 | 159 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Device Inspection Co., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medical Device Inspection Co., Inc. have?
Medical Device Inspection Co., Inc. has 30 FDA 510(k) clearances (first 1990, latest 1995), across 20 product codes in 7 review panels.
How long does FDA take to clear Medical Device Inspection Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical Device Inspection Co., Inc.'s cleared 510(k)s is 106 days.
What devices does Medical Device Inspection Co., Inc. make?
Its most frequent FDA product codes are FSM (Tray, Surgical, Instrument, 4); INQ (Table, Powered, 4); EMA (Cement, Dental, 2).
Has Medical Device Inspection Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Device Inspection Co., Inc. Related entities may recall under other names.
Next steps
- See all 30 Medical Device Inspection Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FSM, Medical Device Inspection Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.