Atlas FDA

FCO

20 FDA 510(k) clearances · Product code

119 daysmedian time to decision
231 days90th percentile
20clearances measured

FDA profile

Official device name
Box, Battery, Rechargeable
Device class
Class I (low risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2005: 14 · 2006: 17 · 2007: 22 · 2008: 2 · 2011: 6 · 2016: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (K946080)Portable Power Systems, Inc.1995-08-02
R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 (K944348)R & D Batteries, Inc.1995-03-23
R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 (K944389)R & D Batteries, Inc.1995-03-23
R&D PART NOS. 5490, 5541, 5358, 5497 (K945870)R & D Batteries, Inc.1995-03-23
R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 (K944388)R & D Batteries, Inc.1995-03-23
RECHARGEABLE BATTERIES (K944521)R & D Batteries, Inc.1995-03-06
R&D PART NOS. 5262, 5543, 5432, 5469 (K945868)R & D Batteries, Inc.1995-03-06
R&D BATTERIES PART NOS. 5186 AND 5230 (K944387)R & D Batteries, Inc.1995-03-02
R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 (K944390)R & D Batteries, Inc.1995-02-27
R&D PART NOS. 5339, 5510, 5514 (K945871)R & D Batteries, Inc.1995-02-27
R&D PART NOS. 5443, 5322, 5448, 5492 (K945869)R & D Batteries, Inc.1995-02-27
R&D BATTERIES PART NOS. 5354 AND 5150 (K944386)R & D Batteries, Inc.1994-12-30
R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 (K944294)R & D Batteries, Inc.1994-12-30
R&D PART 5518, 5306, 5315 AND 5457 (K945867)R & D Batteries, Inc.1994-12-29
NCE REPLACEMENT BATTERIES (K943680)National Custom Ent., Inc.1994-11-04
REPLACEMENT BATTERIES (K943632)National Custom Ent., Inc.1994-11-04
R&D BATTERIES, PART NO. 5025, 5128 AND 5183 (K942018)R & D Batteries, Inc.1994-07-25
R AND D BATTERIES, INC. PART NUMBER 5017 (K933449)R & D Batteries, Inc.1994-03-01
R & D BATTERIES, INC. PART NUMBER 5047 (K935472)R & D Batteries, Inc.1994-02-25
R AND D BATERIES (K934683)R & D Batteries, Inc.1993-11-22

Track FCO automatically

Every clearance here is in the API, with alerts when new ones post.