Atlas FDA

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

Ellman Intl., Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
168 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013255SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RFEllman Intl., Inc.2001-11-07400
K003126BIPOLAR TRIGGER-FLEX PROBEEllman Intl., Inc.2001-04-111880
K001986SURGITRON IEC IIEllman Intl., Inc.2000-09-27900
K001407SURGITRON IEC IIEllman Intl., Inc.2000-07-24810
K001253SURGITRON IEC IIEllman Intl., Inc.2000-05-26370
K992382SURGITRON RADIOLASEEllman Intl., Inc.1999-10-14900
K990146SURGITRONEllman Intl., Inc.1999-03-17570
K980177SUGITRON MODEL: IECEllman Intl., Inc.1998-07-071680
K980170SURGITRONEllman Intl., Inc.1998-06-291600
K972072SURGITRON MODEL FFPF-EMCEllman Intl., Inc.1997-06-19160
K955176DENTO-SURGEEllman Intl., Inc.1996-04-151540
K954718ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGEEllman Intl., Inc.1996-02-291390
K955158SURGITRONEllman Intl., Inc.1996-02-09880
K954703MEDI-FRIGEllman Intl., Inc.1996-02-081190
K955167SURGITRONEllman Intl., Inc.1996-02-08870

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