510(k) Report

FDA applicant

R & D Batteries, Inc.

Burnsville, MN53 decisions1993–20140 recalls

FDA records 53 decisions for R & D Batteries, Inc. (Burnsville, MN) from 1993 to 2014: 53 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and FCO (Box, Battery, Rechargeable). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided R & D Batteries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R & D Batteries, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R & D Batteries, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FLLContinuous Measurement Thermometer19decisions
  • FCOBox, Battery, Rechargeable17decisions
  • HLJOphthalmoscope, Battery-Powered3decisions
  • HGMSystem, Monitoring, Perinatal2decisions
  • BXBExerciser, Powered1decision
  • ETNStimulator, Nerve1decision

Also: IYX (1), JPA (1), MKJ (1), FKX (1), KIJ (1), JAF (1).

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K951281R&D Batteris, Inc. Part Number 5024, 5027, 5033 and 5035R & D Batteries, Inc. · 19952cite it
  • K945869R&D Part Nos. 5443, 5322, 5448, 5492R & D Batteries, Inc. · 19951cites it
  • K942018R&D Batteries, Part NO. 5025, 5128 and 5183R & D Batteries, Inc. · 19941cites it

What has FDA decided for it lately?

  • K141795Batter Pack, Replacement for Physio Control Lifepak 500R & D Batteries, Inc. · 2014
  • K951283R&D Batteries, Inc. Part Numbers 5075-B, 5076, 5122 and 5123R & D Batteries, Inc. · 1995
  • K951402R&D Batteries Part Nos. 5167, 5221, 5244 and 5247R & D Batteries, Inc. · 1995
  • K951399R&D Batteries Part Nos. 5041 & 5655R & D Batteries, Inc. · 1995
  • K951400R&D Batteries Part Nos. 5064, 5157, 5489 and 5536R & D Batteries, Inc. · 1995
  • K951403R&D Batteries Part Nos. 5164, 5252, 5634 and 5650R & D Batteries, Inc. · 1995
  • K951276R&D Batteries, Inc. Part Numbers 5412, 5420, 5436 and 5438R & D Batteries, Inc. · 1995
  • K951274R&D Battries, Inc. Part Numbers 5601, 5602, 5624 and 5626R & D Batteries, Inc. · 1995

All 53 as R & D Batteries, Inc. →