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

Chalgren Enterprises, Inc. — Predicate Candidate Screening

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

164 daysmedian FDA review time
305 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 2Chalgren Enterprises, Inc.1999-06-223050
K960591RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STPChalgren Enterprises, Inc.1996-06-131220
K955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODEChalgren Enterprises, Inc.1996-01-29700
K953354EMG DISC RECORDING ELECTRODEChalgren Enterprises, Inc.1996-01-221890
K953356EMG RECORDING RING ELECTRODEChalgren Enterprises, Inc.1996-01-221890
K953361EMG DISC RECORDING ELECTRODEChalgren Enterprises, Inc.1996-01-221890
K952690EMG DISC RECORDING ELECTRODE WITH PINChalgren Enterprises, Inc.1995-12-061770
K952908EMG DISC RECORDING ELECTRODE WITH PINChalgren Enterprises, Inc.1995-12-061660
K953886RE-USABLE MONOPOLAR NEEDLEChalgren Enterprises, Inc.1995-10-31750
K953887RE-USABLE CONCENTRIC NEEDLEChalgren Enterprises, Inc.1995-10-31750
K95322032MM NICKEL PLATED DISC ELECTRODEChalgren Enterprises, Inc.1995-10-06880
K95321922MM STAINLESS STEEL DISC ELECTRODE, WITH PINChalgren Enterprises, Inc.1995-10-06880
K924277DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDINGChalgren Enterprises, Inc.1994-12-078340
K931029DISPOSABLE CONCENTRIC NEEDLE ELECTRODEChalgren Enterprises, Inc.1994-08-255420
K924521DISPOSABLE CONCENTRIC NEEDLE ELECTRODEChalgren Enterprises, Inc.1993-02-121570
K925706REUSABLE FINGER CLIP RECORDING ELECTRODEChalgren Enterprises, Inc.1993-02-10900
K923665REUSABLE DUAL DISC BAR RECORDING ELECTRODESChalgren Enterprises, Inc.1992-10-05750
K921504REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELSChalgren Enterprises, Inc.1992-09-111640
K912282DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELSChalgren Enterprises, Inc.1992-03-162930
K912283DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODEChalgren Enterprises, Inc.1992-03-162981
K896370DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)Chalgren Enterprises, Inc.1989-12-22460

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