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

Sunrise Medical, Inc. — Predicate Candidate Screening

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

38 daysmedian FDA review time
217 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K072153QUICKIE QX MANUAL FOLDING WHEELCHAIRSunrise Medical, Inc.2007-09-10380
K062701QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIRSunrise Medical, Inc.2006-09-25140
K031289QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424Sunrise Medical, Inc.2003-05-09161
K011268BREEZY WHEELCHAIR, MODEL 300Sunrise Medical, Inc.2001-05-15190
K010917POWER TILT AND RECLINE SYSTEMSunrise Medical, Inc.2001-05-15490
K001491QUICKIE 2 POWER ASSIST WHEELCHAIRSunrise Medical, Inc.2000-12-152170
K981885SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MSunrise Medical, Inc.1998-11-121670
K983677QUICKIE G SERIES, MODEL G-424Sunrise Medical, Inc.1998-11-06180
K983520BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL,Sunrise Medical, Inc.1998-11-06290
K981462QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIESunrise Medical, Inc.1998-11-061970
K983639ZIPPIE GS, MODEL # EIZGSSunrise Medical, Inc.1998-10-2590
K982989QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTRSunrise Medical, Inc.1998-10-05400
K974820BREEZY SERIESSunrise Medical, Inc.1998-01-27350
K973673QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING Sunrise Medical, Inc.1997-11-20554
K972797TOOL-LESS WHEEL CHAIRSunrise Medical, Inc.1997-08-12150
K952641QUICKIE TSRSunrise Medical, Inc.1995-07-06270
K944423POWER RECLINERSunrise Medical, Inc.1994-11-28890
K925112BIO CLINIC UNDER PATIENT SCALESunrise Medical, Inc.1993-06-182520
K922205BIO THERAPY PLUSSunrise Medical, Inc.1992-08-11910

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