R & D Batteries, Inc.: FDA filings under this applicant name
FDA lists 53 510(k) clearances under the applicant name “R & D Batteries, Inc.” (first 1993, latest 2014), across 16 product codes in 11 review panels. Median 510(k) review time under this name: 150 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 | 1 | 158 |
| 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 19 | 19 |
| FCO | Box, Battery, Rechargeable | 17 | 17 |
| HLJ | Ophthalmoscope, Battery-Powered | 3 | 3 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BXB | Exerciser, Powered | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
Plus 6 more product codes.
Review panels
- General Hospital (19)
- Gastroenterology and Urology (18)
- Ophthalmic (4)
- Cardiovascular (2)
- Obstetrics and Gynecology (2)
- Physical Medicine (2)
- Radiology (2)
- Ear, Nose and Throat (1)
- Hematology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent R & D Batteries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | MKJ | 2014-12-08 | 158 |
| K951404 | R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131 | FLL | 1995-08-18 | 143 |
| K951403 | R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650 | FLL | 1995-08-18 | 143 |
| K951402 | R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247 | FLL | 1995-08-18 | 143 |
| K951401 | R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051 | FLL | 1995-08-18 | 143 |
| K951400 | R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536 | FLL | 1995-08-18 | 143 |
| K951399 | R&D BATTERIES PART NOS. 5041 & 5655 | FLL | 1995-08-18 | 143 |
| K951285 | R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172 | FLL | 1995-08-18 | 150 |
| K951284 | R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155 | FLL | 1995-08-18 | 150 |
| K951283 | R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123 | FLL | 1995-08-18 | 150 |
43 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named R & D Batteries, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under R & D Batteries, Inc. (a text match, not an official crosswalk):
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via FCO)
Frequently asked questions
How many FDA 510(k) clearances are listed under R & D Batteries, Inc.?
FDA lists 53 510(k) clearances under the applicant name “R & D Batteries, Inc.” (first 1993, latest 2014), across 16 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 R & D Batteries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R & D Batteries, Inc. is 150 days.
Which FDA product codes appear under R & D Batteries, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 19); FCO (Box, Battery, Rechargeable, 17); HLJ (Ophthalmoscope, Battery-Powered, 3).
Next steps
- See all 53 R & D Batteries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, R & D Batteries, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.