Atlas FDA

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

Aesculap-Meditec North America · Predicate Candidate Screening

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

88 daysmedian FDA review time
178 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994116LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTAesculap-Meditec North America2000-06-011780
K992707MCL 29 DERMABLATE ER:YAG LASER SYSTEMAesculap-Meditec North America1999-10-19690
K991285LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODEAesculap-Meditec North America1999-07-12880
K981196MEDITEC LINKAesculap-Meditec North America1998-06-17900
K980361DERMABLATE ER: YAG LASER SYSTEMAesculap-Meditec North America1998-04-21820
K974467AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08Aesculap-Meditec North America1998-02-19850

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