Atlas FDA

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

Pro Med Instruments GmbH — Predicate Candidate Screening

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

114 daysmedian FDA review time
235 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (3Pro Med Instruments GmbH2024-07-26280
K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pro Med Instruments GmbH2024-04-24820
K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH2021-03-291190
K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Pro Med Instruments GmbH2020-06-021740
K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH2020-02-212350
K191979DORO QR3 XTom Headholder SystemPro Med Instruments GmbH2019-10-22900
K063494DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND Pro-Med Instruments GmbH2007-05-211820
K070997DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DOPro-Med Instruments GmbH2007-05-16370
K032331DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,ANDPro-Med Instruments GmbH2003-11-201143
K001808DORO HEADREST SYSTEMPro-Med Instruments GmbH2000-08-04501

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