Parker Laboratories, Inc.: FDA clearances and approvals
Parker Laboratories, Inc. has 30 FDA 510(k) clearances (first 1977, latest 2024), across 20 product codes in 7 review panels. Median 510(k) review time: 50 days. openFDA lists 4 product recalls by a recalling firm named Parker Laboratories, Inc.
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 | 1 | 244 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Parker Laboratories, Inc.'s cleared 510(k)s took a median 244 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GYB | Media, Electroconductive | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| DZN | Instruments, Dental Hand | 1 | 1 |
| EAQ | Detector, Ultraviolet | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EFH | Paper, Articulation | 1 | 1 |
Plus 10 more product codes.
Review panels
- Dental (12)
- Radiology (6)
- Neurology (5)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Physical Medicine (1)
Most recent Parker Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | ITX | 2024-08-15 | 244 |
| K953673 | ECLIPSE PROBE COVER | IYO | 1996-03-14 | 220 |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | ITX | 1995-02-23 | 1051 |
| K864556 | AQUALUBE(TM) | KMJ | 1986-12-01 | 12 |
| K861239 | ACRYLIC SOLDER | EBI | 1986-04-17 | 15 |
| K855167 | DYNA SYSTEM | EGG | 1986-03-04 | 68 |
| K851895 | POLYGEL ULTRASOUND GEL | IYO | 1985-09-27 | 150 |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | GYB | 1985-08-09 | 29 |
| K841400 | NEURO PULSE | GZJ | 1984-06-15 | 73 |
| K840548 | RESIL | EBI | 1984-04-17 | 69 |
20 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 2 initiated in the last five years. Most recent: 2024-03-22.
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 Parker Laboratories, Inc. have?
Parker Laboratories, Inc. has 30 FDA 510(k) clearances (first 1977, latest 2024), across 20 product codes in 7 review panels.
How long does FDA take to clear Parker Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Parker Laboratories, Inc.'s cleared 510(k)s is 50 days.
What devices does Parker Laboratories, Inc. make?
Its most frequent FDA product codes are GYB (Media, Electroconductive, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2).
Has Parker Laboratories, Inc. had device recalls?
openFDA lists 4 product recalls in 4 recall events by a recalling firm whose name matches Parker Laboratories, Inc; the most recent began 2024-03-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 30 Parker Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GYB, Parker Laboratories, 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.