Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Otto Bock Healthcare LP · Predicate Candidate Screening

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

122 daysmedian FDA review time
301 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213587MyCRO BandOtto Bock Healthcare LP2022-06-092090
K201426MyCRO BandOtto Bock Healthcare LP2021-03-263010
K113164DISCOVERY TMAX MANUAL WHEELCHAIROtto Bock Healthcare LP2013-03-115020
K111278Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICEOtto Bock Healthcare LP2011-09-161340
K111045CENTRO FAMILY OF MANUAL WHEELCHAIRSOtto Bock Healthcare LP2011-07-15910
K101524C2000 POWERED WHEELCHAIROtto Bock Healthcare LP2010-09-291190
K082314BRAVORACER PEDIATRIC MANUAL WHEELCHAIROtto Bock Healthcare LP2008-10-28760
K073512START JUNIOROtto Bock Healthcare LP2008-01-14310
K070318SKIPPI POWERED WHEELCHAIR FOR CHILDRENOtto Bock Healthcare LP2007-05-11980
K052771SENSOR WALKOtto Bock Healthcare LP2006-05-032150
K052706A-200 POWERED WHEELCHAIROtto Bock Healthcare LP2005-12-27900
K052681START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HOtto Bock Healthcare LP2005-10-0680
K041208POWERED WHEELCHAIR, MODEL B-500Otto Bock Healthcare LP2004-10-011440
K041210POWERED WHEELCHAIR, MODEL B-600Otto Bock Healthcare LP2004-10-011440
K041211POWERED WHEELCHAIR, MODEL C-1000Otto Bock Healthcare LP2004-10-011440
K041215CRANIAL HELMETOtto Bock Healthcare LP2004-09-091220
K032833MYOSYSTEM WITH CUSTOMIZINGOtto Bock Healthcare LP2003-09-23120

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