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

Stockert Instrumente GmbH — Predicate Candidate Screening

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

39 daysmedian FDA review time
238 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042374STOCKERT SCP RHYTHMStockert Instrumente GmbH2004-09-23220
K041558STOCKERTIR PURGE CONTROL (APC) SYSTEMStockert Instrumente GmbH2004-07-02220
K032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMPStockert Instrumente GmbH2003-08-29390
K023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THStockert Instrumente GmbH2002-11-21230
K022280STOCKERT CORONARY PERFUSION CANNULAEStockert Instrumente GmbH2002-10-11880
K022321STOCKERT V172-28 VENOUS FEMORAL CANNULAStockert Instrumente GmbH2002-10-09840
K020571STOCKERT CENTRIFUGAL PUMP CONSOLEStockert Instrumente GmbH2002-09-232140
K011838CENTRIFUGAL PUMPStockert Instrumente GmbH2002-02-052382
K011088SIII ALARM AMPLIFIERStockert Instrumente GmbH2001-05-02220

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