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

Adler Instrument Co. · Predicate Candidate Screening

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

44 daysmedian FDA review time
154 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910171MAXI-FLOW SUCTION SET W/Y CONNECTORAdler Instrument Co.1991-02-01170
K910170MAXI-FLOW SUCTION SET 12 FT.Adler Instrument Co.1991-02-01170
K903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.1990-12-211540
K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.1990-12-171500
K900913ADLER DISPOSABLE BIPOLAR CORDAdler Instrument Co.1990-04-04360
K841723ADLER CUSTOM PROCEDURE PACKSAdler Instrument Co.1984-08-01980
K833264ADLER STEAM INDICATOR-GAS INDICATORAdler Instrument Co.1983-11-03440
K831068CONTAINER SYSTEMAdler Instrument Co.1983-05-09350

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