Abco Dealers, Inc.: FDA clearances and approvals
Abco Dealers, Inc. has 127 FDA 510(k) clearances (first 1976, latest 1991), across 72 product codes in 13 review panels. Median 510(k) review time: 29 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 |
|---|---|---|---|
| KOD | Catheter, Urological | 9 | 9 |
| FMF | Syringe, Piston | 7 | 7 |
| DXQ | Blood Pressure Cuff | 5 | 5 |
| EFQ | Gauze/Sponge, Internal | 5 | 5 |
| FLL | Continuous Measurement Thermometer | 4 | 4 |
| KGX | Tape And Bandage, Adhesive | 4 | 4 |
| FLK | Thermometer, Clinical Mercury | 3 | 3 |
| FQM | Bandage, Elastic | 3 | 3 |
| FXP | Cover, Shoe, Operating-Room | 3 | 3 |
| FXX | Mask, Surgical | 3 | 3 |
Plus 62 more product codes.
Review panels
- General Hospital (56)
- General and Plastic Surgery (21)
- Gastroenterology and Urology (13)
- Cardiovascular (9)
- Physical Medicine (5)
- Ear, Nose and Throat (3)
- Anesthesiology (2)
- Pathology (2)
- Clinical Chemistry (1)
- Hematology (1)
- Microbiology (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Abco Dealers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905025 | DIGITAL THERMOMETER KITS | FLL | 1991-02-07 | 92 |
| K882304 | DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) | FLL | 1988-07-12 | 39 |
| K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS | FMI | 1988-04-21 | 50 |
| K880894 | ALLERGIST SYRINGES | FMF | 1988-03-31 | 29 |
| K872875 | STRETCH GAUZE BANDAGES | NAD | 1987-09-04 | 45 |
| K872874 | MICROSCOPE COVER GLASSES | KES | 1987-08-10 | 20 |
| K872797 | NON-SKID SHOE COVERS | FXP | 1987-08-04 | 20 |
| K871465 | THERMOMETER SHEATHS | FLL | 1987-05-11 | 27 |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | FXP | 1986-08-01 | 14 |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | — | 1986-07-08 | 35 |
117 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Abco Dealers, 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 Abco Dealers, Inc. have?
Abco Dealers, Inc. has 127 FDA 510(k) clearances (first 1976, latest 1991), across 72 product codes in 13 review panels.
How long does FDA take to clear Abco Dealers, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Abco Dealers, Inc.'s cleared 510(k)s is 29 days.
What devices does Abco Dealers, Inc. make?
Its most frequent FDA product codes are KOD (Catheter, Urological, 9); FMF (Syringe, Piston, 7); DXQ (Blood Pressure Cuff, 5).
Has Abco Dealers, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Abco Dealers, Inc. Related entities may recall under other names.
Next steps
- See all 127 Abco Dealers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOD, Abco Dealers, 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.