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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Portable Power Systems, Inc. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

197 daysmedian FDA review time
332 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970234SEALED LEAD ACID BATTERY PACKPortable Power Systems, Inc.1997-05-021010
K946080PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATORPortable Power Systems, Inc.1995-08-022320
K945043BATTERY PACK #PMX120-18APortable Power Systems, Inc.1995-01-20980
K932823BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECKPortable Power Systems, Inc.1994-02-172530
K934015RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIBPortable Power Systems, Inc.1994-02-171840
K934508BATTERY PACK# S1024NCPortable Power Systems, Inc.1994-02-171560
K934439RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONIPortable Power Systems, Inc.1994-02-171780
K931483REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.Portable Power Systems, Inc.1994-02-173300
K933065BATTERY PACK# S1009LAPortable Power Systems, Inc.1994-02-172400
K931484REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 SPortable Power Systems, Inc.1994-02-173300
K931348BATTERY PACK #1005NCPortable Power Systems, Inc.1994-02-173370
K931716BATTERY PACK 1017LAPortable Power Systems, Inc.1994-02-073070
K931266BATTERY PACK #1012NCPortable Power Systems, Inc.1994-02-033320
K925675BATTERY PACK #1015NCPortable Power Systems, Inc.1993-05-261970
K925674BATTERY PACK #1014NCPortable Power Systems, Inc.1993-05-261970
K925449REPLACEMENT RECHARGEABLE BATTERY PACK'SPortable Power Systems, Inc.1993-04-291830
K924798BATTERY PACKPortable Power Systems, Inc.1992-10-16220
K923864BATTERY PACKPortable Power Systems, Inc.1992-10-05630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda