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

Biotrack, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
213 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSBiotrack, Inc.1993-12-291320
K934061BIOTRACK VALPROIC ACID TEST CARTRIDGEBiotrack, Inc.1993-12-291320
K920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLBiotrack, Inc.1992-08-051830
K915755BIOTRACK PHENYTOIN TEST CARTRIDGEBiotrack, Inc.1992-07-232130
K915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEBiotrack, Inc.1992-07-232130
K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSBiotrack, Inc.1990-09-17240
K900373BIOTRACK THEOPHYLLINE TEST CARTRIDGEBiotrack, Inc.1990-05-301240
K900372BIOTRACK IMMUNOCHEMISTRY MONITORBiotrack, Inc.1990-02-23280
K895101BIOTRACK HEMOGLOBIN TEST CARTRIDGEBiotrack, Inc.1989-10-10560
K895102BIOTRACK PDS MONITORBiotrack, Inc.1989-10-10560
K895128BIOTRACK ALT TEST CARTRIDGEBiotrack, Inc.1989-10-06500
K890052BIOTRACK APTT REAGENT CARTRIDGEBiotrack, Inc.1989-02-24490
K890051BIOTRACK APTT CONTROLSBiotrack, Inc.1989-02-23480
K860719BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)Biotrack, Inc.1986-05-23861
K860721BIOTRACK PROTIME TEST PROTHROMBIN TIME TESTBiotrack, Inc.1986-05-23860
K860720BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)Biotrack, Inc.1986-05-23860

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