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

Fiberoptic Sensor Technlogies, Inc. — Predicate Candidate Screening

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

96 daysmedian FDA review time
406 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945753FST FIBEROPTIC PRESSURE CONVERTERFiberoptic Sensor Technlogies, Inc.1995-05-111690
K950908FST CATH-UD, CATHETERFiberoptic Sensor Technlogies, Inc.1995-04-07500
K9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONFiberoptic Sensor Technlogies, Inc.1995-02-09930
K930171FST DUAL, DUAL PRESSURE URODYNAMICS MONITORFiberoptic Sensor Technlogies, Inc.1993-11-042950
K922476URO-PRO 2000Fiberoptic Sensor Technlogies, Inc.1993-07-204200
K922776FST COUNCIL TIP FOLEY CATHETERFiberoptic Sensor Technlogies, Inc.1993-07-204060
K926088FST CATH UD-DUAL DUAL PRESSURE CATHETERFiberoptic Sensor Technlogies, Inc.1993-06-181980
K913113FST CATH-UD CATHETER, MODIFICATIONFiberoptic Sensor Technlogies, Inc.1991-10-09960
K913721FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEMFiberoptic Sensor Technlogies, Inc.1991-10-08490
K905641FST CATH-UD CATHETERFiberoptic Sensor Technlogies, Inc.1991-02-19630
K864000FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00Fiberoptic Sensor Technlogies, Inc.1987-01-16940

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