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

Paladin Medical, Inc. · Predicate Candidate Screening

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

229 daysmedian FDA review time
444 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERPaladin Medical, Inc.1999-11-03300
K970347MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEMPaladin Medical, Inc.1997-08-292140
K971290STRATASYS FDM MEDMODELER SYSTEMPaladin Medical, Inc.1997-06-20740
K964222ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANINGPaladin Medical, Inc.1996-12-20590
K950054ENDO-BEND(TM) SHAVERPaladin Medical, Inc.1995-06-291740
K935220CORE PREVENT MATTRESS MODIFICATIONPaladin Medical, Inc.1993-11-29480
K921015SHARPE ENDOSPONGE ASPIIRATORPaladin Medical, Inc.1993-05-214440
K915743SHARPE ENDOTENACULUMPaladin Medical, Inc.1993-05-205140
K915747SHARPE ENDOFORCEPSPaladin Medical, Inc.1992-10-203020
K915749SHARPE ENDOLIGATURE CARRIERPaladin Medical, Inc.1992-10-203020
K921888SHARPE ENDODISSECTORPaladin Medical, Inc.1992-10-201820
K915744SHARPE ENDOHEMOSTATPaladin Medical, Inc.1992-10-203020
K920549SHARPE ENDONEEDLE HOLDERPaladin Medical, Inc.1992-09-222290
K920548SHARPE ENDOSCALPELPaladin Medical, Inc.1992-09-222290

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