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

Intersurgical, Inc. — Predicate Candidate Screening

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

198 daysmedian FDA review time
307 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122077MANOMETERIntersurgical, Inc.2013-01-101780
K122075DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTERIntersurgical, Inc.2012-12-201570
K121026FLO-GUARD BREATHING FILTERIntersurgical, Inc.2012-11-022120
K092451INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISIntersurgical, Inc.2010-10-294450
K092129INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATIIntersurgical, Inc.2010-05-183070
K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHIntersurgical, Inc.2010-03-102160
K032322CLEAR-THERM MICRO HME, MODEL 1441Intersurgical, Inc.2004-05-132900
K024270CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUIntersurgical, Inc.2003-06-241830
K990949CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUIntersurgical, Inc.1999-06-15850
K983610CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MIntersurgical, Inc.1999-04-301980
K984481EXHALATION VALVEIntersurgical, Inc.1999-01-29440
K925462BREATHING FILTERS 1942T/1941T/2014TIntersurgical, Inc.1993-05-212040
K921512ENTENDED LINE ACCESSORIES & CONNECTORSIntersurgical, Inc.1992-06-17850
K921511CATHETER MOUNTS -- MODIFICATIONIntersurgical, Inc.1992-06-17850
K911422DRUG NEBULIZERSIntersurgical, Inc.1991-10-232600
K911427BREATHING FILTERSIntersurgical, Inc.1991-08-262020
K911421CATHETER MOUNTSIntersurgical, Inc.1991-06-241390
K911425ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MMIntersurgical, Inc.1991-06-241390

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