Atlas FDA

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

Surgical Dynamics, Inc. — Predicate Candidate Screening

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

146 daysmedian FDA review time
406 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPESurgical Dynamics, Inc.1996-04-02910
K942987NUCLEOTOME L KITSurgical Dynamics, Inc.1995-10-304970
K954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SETSurgical Dynamics, Inc.1995-10-23470
K950495SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000Surgical Dynamics, Inc.1995-05-09920
K931109NUCLEOTOME E KITSurgical Dynamics, Inc.1994-03-293910
K921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMSurgical Dynamics, Inc.1993-06-074060
K923525NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBARSurgical Dynamics, Inc.1993-02-092080
K913145NUCLEOTOME TISSUE ASPIRATOR/CUTTERSurgical Dynamics, Inc.1991-12-191560
K914282NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTERSurgical Dynamics, Inc.1991-12-19860
K902778SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTERSurgical Dynamics, Inc.1990-10-301270
K894336SURGICAL DYNAMICS DISCOGRAPHY SYSTEMSurgical Dynamics, Inc.1989-08-04210
K885066HEMATOME SYSTEMSurgical Dynamics, Inc.1989-05-011460

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