Atlas FDA

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

Patton, Boggs & Blow — Predicate Candidate Screening

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

84 daysmedian FDA review time
424 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943348KLS CHIN PLATE SYSTEMPatton, Boggs & Blow1994-10-04840
K943345MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEMPatton, Boggs & Blow1994-10-04840
K943346MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYPatton, Boggs & Blow1994-10-04840
K943347KLS MINI OSTEOSYNTHESIS SYSTEMPatton, Boggs & Blow1994-10-04840
K821799FITKIT I CHECKUP KITPatton, Boggs & Blow1983-08-164240
K823825NOSITE UV INTERIM SPECTACLESPatton, Boggs & Blow1983-02-24660

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