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

Th Charters, Inc. — Predicate Candidate Screening

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

67 daysmedian FDA review time
85 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K873357ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.Th Charters, Inc.1987-10-26670
K861501EXER-STIM 2Th Charters, Inc.1986-05-08150
K851967TORQUE FEEDBACK METERTh Charters, Inc.1985-07-19740
K851946REMOTE SPEED CONTROLTh Charters, Inc.1985-07-19770
K834215MINI-1 TRANSCUTANEOUS ELEC-NERVE STIMTh Charters, Inc.1984-01-03290
K831850NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVETh Charters, Inc.1983-07-19400
K822056EXER-STIM CONTROLLERTh Charters, Inc.1982-10-06850
K800486STIM-EX 201Th Charters, Inc.1980-03-19150

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