Atlas FDA

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

Berchtold Holding GmbH · Predicate Candidate Screening

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

58 daysmedian FDA review time
203 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083066CHROMOPHARE E 778 AND E 558Berchtold Holding GmbH2008-10-30150
K080857CHROMOPHARE E-SERIESBerchtold Holding GmbH2008-04-10140
K024132CHROMOPHARE X 65Berchtold Holding GmbH2003-03-21950
K990656CHROMOPHARE D 530 LDR SURGICAL LIGHTBerchtold Holding GmbH1999-07-201410
K991527CHROMOPHARE D500, D530, D650Berchtold Holding GmbH1999-05-27240
K974433CHROMOPHARE D 500, CHROMOPHARE D 530Berchtold Holding GmbH1998-02-20880
K965130CHROMOPHAREBerchtold Holding GmbH1997-07-142030
K955750TELETOMBerchtold Holding GmbH1996-02-08520
K950932BIPOLAP HOOK ELECTRODEBerchtold Holding GmbH1995-03-15140
K944855CHROMOPHAREBerchtold Holding GmbH1994-10-19190
K942319HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLESBerchtold Holding GmbH1994-06-08260
K940405TELETOMBerchtold Holding GmbH1994-04-14770
K935832CHROMOPHAREBerchtold Holding GmbH1994-02-03580
K922836CHROMOPHAREBerchtold Holding GmbH1992-10-091191
K915608BICUTBerchtold Holding GmbH1992-07-232200
K921626TELETOM(R)Berchtold Holding GmbH1992-05-05290

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