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

Innovative Medical Systems, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
110 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973035VIOLA II DENTAL CAMERA SYSTEMInnovative Medical Systems, Inc.1997-09-24410
K951469BAZOOKA SYSTEMInnovative Medical Systems, Inc.1995-06-28900
K933184POSITIVE AIRWAY PRESSURE SYSTEMInnovative Medical Systems, Inc.1994-11-285160
K924590MICROWAVE AUTOMATED TISSUE PROCESSORInnovative Medical Systems, Inc.1992-12-291100
K922081LABOTECH AUTOMATED MICROTITER ANALYZERInnovative Medical Systems, Inc.1992-09-021200
K921005AUTOLOADERInnovative Medical Systems, Inc.1992-04-29570
K915457PHACO 20/20 SYSTEM IInnovative Medical Systems, Inc.1992-02-24810
K915456PHACO 3000 LINEARInnovative Medical Systems, Inc.1992-02-12690
K883599LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)Innovative Medical Systems, Inc.1988-09-02100
K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.1988-04-27630
K853938LX 300 TISSUE PROCESSORInnovative Medical Systems, Inc.1985-10-10160
K853463LX EMBEDDING CENTERInnovative Medical Systems, Inc.1985-08-2890
K851054LX120 TISSUE PROCESSORInnovative Medical Systems, Inc.1985-05-15620
K842077MIDAS II AUTOMATIC STAINERInnovative Medical Systems, Inc.1984-07-27650
K832994MIDAS 6000 AUTOMATIC STAINERInnovative Medical Systems, Inc.1983-09-29270
K823522DILULAB 230Innovative Medical Systems, Inc.1982-12-28290
K823124IMS HEMATOLOGY MIXERInnovative Medical Systems, Inc.1982-11-22310
K821830MI DAS 1000 AUTOMATIC SLIDE STAINERInnovative Medical Systems, Inc.1982-07-22300
K801513TISSUE PROCESSING SYSTEMInnovative Medical Systems, Inc.1980-07-28280
K781361HEMOGLOBINOMETER MODEL 720 BInnovative Medical Systems, Inc.1978-09-14380
K780882DILUTER/DISPENSERInnovative Medical Systems, Inc.1978-06-28290
K780789PERALISTIC PUMP MODEL 2000Innovative Medical Systems, Inc.1978-06-13290

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