Atlas FDA

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

Panpac Medical Corporation · Predicate Candidate Screening

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

281 daysmedian FDA review time
371 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation2018-10-313710
K161106PANPAC DISPOSABLE VACUUM CURETTESPanpac Medical Corporation2017-01-132690
K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation2016-07-142320
K132670PANPAC INFLATABLE DOCUT PESSARYPanpac Medical Corporation2014-06-042810
K130087PANPAC WORD/BARTHOLIN CATHETERPanpac Medical Corporation2014-01-103610
K130273PANPAC VAGINAL DILATORSPanpac Medical Corporation2013-08-081850
K102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOPanpac Medical Corporation2011-12-154410
K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation2010-07-263010
K092981PANPAC VAGINAL PESSARYPanpac Medical Corporation2010-07-222970
K092983PANPAC HSG CATHETER SETPanpac Medical Corporation2010-06-072520
K092984PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0Panpac Medical Corporation2010-04-071910
K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5Panpac Medical Corporation2010-03-111640

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