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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Predicate Candidate Screening

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

207 daysmedian FDA review time
368 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K031014HI-FLO THERME PNEU 45, WISAP #7083, 7083VWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2003-06-27880
K011510MULTI HI-FLO PNEU, WISAP #7080Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2002-04-023210
K992481CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMFWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2000-03-172350
K992513THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2000-03-172350
K990662DISPOSABLE HEATING TUBING SET #7642HSESWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-09-242070
K982515POWER-DRIVE, WISAP MODEL #7688PD/7688PD1Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-01-191830
K982518AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-01-141780
K960640S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1997-02-143680
K952508FLOW-THERME, WISAP #7642Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1995-08-25860

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