Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fisher & Paykel Electronics , Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
408 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973161 | CPAP HUMIDIFIER (HC 200) | Fisher & Paykel Electronics , Ltd. | 1998-07-10 | 322 | 0 |
| K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, | Fisher & Paykel Electronics , Ltd. | 1997-10-30 | 86 | 0 |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT | Fisher & Paykel Electronics , Ltd. | 1997-07-28 | 81 | 0 |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL | Fisher & Paykel Electronics , Ltd. | 1997-07-16 | 86 | 1 |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | Fisher & Paykel Electronics , Ltd. | 1997-05-07 | 92 | 2 |
| K953392 | HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCE | Fisher & Paykel Electronics , Ltd. | 1996-03-12 | 237 | 0 |
| K953711 | AIR ENTRAINER 900RT008 | Fisher & Paykel Electronics , Ltd. | 1995-11-08 | 91 | 0 |
| K953949 | HUMIDIFIER & ACCESSORIES | Fisher & Paykel Electronics , Ltd. | 1995-10-16 | 55 | 0 |
| K934140 | MR290 HUMIDIFICATION CHAMBER SINGLE USE | Fisher & Paykel Electronics , Ltd. | 1994-01-24 | 152 | 0 |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | Fisher & Paykel Electronics , Ltd. | 1993-05-27 | 276 | 0 |
| K915460 | HEATED RESPIRATORY HUMIDIFIER HC100 | Fisher & Paykel Electronics , Ltd. | 1993-01-15 | 408 | 0 |
| K913367 | MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS | Fisher & Paykel Electronics , Ltd. | 1992-06-25 | 337 | 0 |
| K902386 | MODEL TM101 TEMPERATURE MONITOR | Fisher & Paykel Electronics , Ltd. | 1992-01-28 | 608 | 0 |
| K913368 | MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC | Fisher & Paykel Electronics , Ltd. | 1992-01-13 | 173 | 0 |
| K892817 | HEATED RESPIRATORY HUMIDIFIER | Fisher & Paykel Electronics , Ltd. | 1989-12-21 | 248 | 0 |
| K892885 | RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR | Fisher & Paykel Electronics , Ltd. | 1989-10-06 | 170 | 0 |
| K883868 | MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM | Fisher & Paykel Electronics , Ltd. | 1988-11-28 | 76 | 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