Atlas FDA

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

Waters Instruments, Inc. — Predicate Candidate Screening

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

98 daysmedian FDA review time
206 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K053169RM3 RENAL PRESERVATION SYSTEMWaters Instruments, Inc.2006-01-17640
K042224RM3 RENAL PRESERVATION SYSTEMWaters Instruments, Inc.2004-10-22660
K971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITWaters Instruments, Inc.1997-07-29900
K921519OXICOM-2100Waters Instruments, Inc.1992-10-232060
K911207OXICOMPLUSWaters Instruments, Inc.1991-08-261600
K863210VELCOM-100Waters Instruments, Inc.1986-11-26980
K862161OSC-80 OXIMETERWaters Instruments, Inc.1986-08-18730
K852909MVP - 6000Waters Instruments, Inc.1985-11-141280
K834408TX-2 THERMAL DILUTION CARDIAC OUTPUTWaters Instruments, Inc.1984-08-232530
K841876POLYURETHANE THERMAL DILUTION CATHETWaters Instruments, Inc.1984-07-13670
K813585WATERS ILEOSTOMY VALVEWaters Instruments, Inc.1982-04-091020
K813494WATERS ILEAL RESERVOIR CATHETERWaters Instruments, Inc.1981-12-31170

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