Atlas FDA

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

Laborie Medical Tech Corp. — Predicate Candidate Screening

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

86 daysmedian FDA review time
302 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESLaborie Medical Tech Corp.1999-11-29260
K990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESLaborie Medical Tech Corp.1999-08-052110
K991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech Corp.1999-07-07700
K963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMLaborie Medical Tech Corp.1997-06-053020
K950016CART, MODE NUMBER UDS-CARTLaborie Medical Tech Corp.1995-03-30860

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