Atlas FDA

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

Biospace Corporation Limited · Predicate Candidate Screening

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

144 daysmedian FDA review time
249 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141483BIOSPACE BODY COMPOSITION ANALYZERBiospace Corporation Limited2014-09-231100
K130777INBODYBiospace Corporation Limited2013-11-252490
K131064BIOSPACEBiospace Corporation Limited2013-09-041410
K123228INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)Biospace Corporation Limited2013-03-081440
K110689INBODYBiospace Corporation Limited2011-08-191570
K092786INBODY, MODELS: 270, R20, R20BBiospace Corporation Limited2010-03-101810
K062603BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230Biospace Corporation Limited2007-02-151670
K052646BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 Biospace Corporation Limited2005-12-16810
K042528INBODY, MODEL 3.0Biospace Corporation Limited2005-01-111160

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