Consolidated Medical Equipment, Inc.: FDA clearances and approvals
Consolidated Medical Equipment, Inc. has 15 FDA 510(k) clearances (first 1980, latest 1986), across 9 product codes in 4 review panels. Median 510(k) review time: 50 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| GXY | Electrode, Cutaneous | 3 | 3 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| KMK | Device, Intravascular Catheter Securement | 2 | 2 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Consolidated Medical Equipment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854040 | I.V. DRESSING | KMK | 1986-01-09 | 99 |
| K850132 | DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC | DRX | 1985-04-09 | 85 |
| K850130 | PRN ECG ELECTRODE | DRX | 1985-04-09 | 85 |
| K850037 | CLOSED WOUND DRAIN | GCY | 1985-03-19 | 71 |
| K844942 | PLURA-GARD CHEST DRAINAGE SYSTEM | KDQ | 1985-03-12 | 82 |
| K850311 | DISPOS. CONDUCTIVE ADHESIVE TENS PAD | GXY | 1985-03-05 | 39 |
| K850131 | CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS | GXY | 1985-03-05 | 50 |
| K850133 | VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. | KGX | 1985-02-28 | 45 |
| K850129 | MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN | GEI | 1985-02-28 | 45 |
| K844372 | HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE | GEI | 1985-02-21 | 100 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Consolidated Medical Equipment, 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 Consolidated Medical Equipment, Inc. have?
Consolidated Medical Equipment, Inc. has 15 FDA 510(k) clearances (first 1980, latest 1986), across 9 product codes in 4 review panels.
How long does FDA take to clear Consolidated Medical Equipment, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Consolidated Medical Equipment, Inc.'s cleared 510(k)s is 50 days.
What devices does Consolidated Medical Equipment, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); GXY (Electrode, Cutaneous, 3); DRX (Electrode, Electrocardiograph, 2).
Has Consolidated Medical Equipment, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Consolidated Medical Equipment, Inc. Related entities may recall under other names.
Next steps
- See all 15 Consolidated Medical Equipment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Consolidated Medical Equipment, 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.