Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FCO — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
231 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946080 | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | Portable Power Systems, Inc. | 1995-08-02 | 232 | 0 |
| K944348 | R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 | R & D Batteries, Inc. | 1995-03-23 | 198 | 0 |
| K944389 | R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 | R & D Batteries, Inc. | 1995-03-23 | 197 | 0 |
| K945870 | R&D PART NOS. 5490, 5541, 5358, 5497 | R & D Batteries, Inc. | 1995-03-23 | 112 | 0 |
| K944388 | R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 | R & D Batteries, Inc. | 1995-03-23 | 197 | 0 |
| K944521 | RECHARGEABLE BATTERIES | R & D Batteries, Inc. | 1995-03-06 | 171 | 0 |
| K945868 | R&D PART NOS. 5262, 5543, 5432, 5469 | R & D Batteries, Inc. | 1995-03-06 | 95 | 0 |
| K944387 | R&D BATTERIES PART NOS. 5186 AND 5230 | R & D Batteries, Inc. | 1995-03-02 | 176 | 0 |
| K944390 | R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 | R & D Batteries, Inc. | 1995-02-27 | 173 | 0 |
| K945871 | R&D PART NOS. 5339, 5510, 5514 | R & D Batteries, Inc. | 1995-02-27 | 88 | 0 |
| K945869 | R&D PART NOS. 5443, 5322, 5448, 5492 | R & D Batteries, Inc. | 1995-02-27 | 88 | 0 |
| K944386 | R&D BATTERIES PART NOS. 5354 AND 5150 | R & D Batteries, Inc. | 1994-12-30 | 114 | 0 |
| K944294 | R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 | R & D Batteries, Inc. | 1994-12-30 | 119 | 0 |
| K945867 | R&D PART 5518, 5306, 5315 AND 5457 | R & D Batteries, Inc. | 1994-12-29 | 28 | 0 |
| K943680 | NCE REPLACEMENT BATTERIES | National Custom Ent., Inc. | 1994-11-04 | 101 | 0 |
| K943632 | REPLACEMENT BATTERIES | National Custom Ent., Inc. | 1994-11-04 | 101 | 0 |
| K942018 | R&D BATTERIES, PART NO. 5025, 5128 AND 5183 | R & D Batteries, Inc. | 1994-07-25 | 90 | 0 |
| K933449 | R AND D BATTERIES, INC. PART NUMBER 5017 | R & D Batteries, Inc. | 1994-03-01 | 231 | 0 |
| K935472 | R & D BATTERIES, INC. PART NUMBER 5047 | R & D Batteries, Inc. | 1994-02-25 | 120 | 0 |
| K934683 | R AND D BATERIES | R & D Batteries, Inc. | 1993-11-22 | 53 | 0 |
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