Atlas FDA

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

King & Spalding — Predicate Candidate Screening

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

80 daysmedian FDA review time
271 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942422PANASONIC WRIST BLOOD PRESSURE METERKing & Spalding1995-02-152710
K942423NAIS WRIST BLOOD PRESSURE METERKing & Spalding1995-02-152710
K945998CHIN IMPLANT STYLE IKing & Spalding1995-02-07690
K944408IMPLANTECH MEDICAL GRADE SILICONE SHEETINGKing & Spalding1994-11-09620
K942421IMPLANTECH LATERAL MANDIBULAR BAR IMPLANTKing & Spalding1994-08-08800
K942420IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANTKing & Spalding1994-08-08800
K941972HEMO-O-LOKKing & Spalding1994-06-29680

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