Atlas FDA

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

Innovative Diagnostic Systems, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time
116 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.1996-10-08700
K943621RAPID YEAST PLUS SYSTEMInnovative Diagnostic Systems, Inc.1995-01-271842
K900517RAPID NF SYSTEMInnovative Diagnostic Systems, Inc.1990-03-13390
K882960IDS RAPID ANA SYSTEMInnovative Diagnostic Systems, Inc.1988-08-12290
K881501MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.1988-05-18370
K852871IDS RAPID SS/U SYSTEMInnovative Diagnostic Systems, Inc.1985-07-23150
K852110IDS RAPID E PLUS SYSTEMInnovative Diagnostic Systems, Inc.1985-06-04200
K833654IDS RAPID STR SYSTEMInnovative Diagnostic Systems, Inc.1984-02-131160
K822144IDS STAPHYLOCHROME TESTInnovative Diagnostic Systems, Inc.1982-08-24340
K820483IDA RAPID O2A SYSTEMInnovative Diagnostic Systems, Inc.1982-03-15210
K812859IDS PORPHYRIN REAGENTInnovative Diagnostic Systems, Inc.1981-10-26130

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