Atlas FDA

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

Palco Laboratories, Inc. — Predicate Candidate Screening

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

120 daysmedian FDA review time
434 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942810PALCO LABS COLD POUCHPalco Laboratories, Inc.1995-06-283780
K943842PULSE OXIMETER MODEL 305Palco Laboratories, Inc.1995-03-242310
K920066PALCO LABS MODEL 340 PULSE OXIMETERPalco Laboratories, Inc.1993-03-164340
K913694PALCO LABS LOADMATICPalco Laboratories, Inc.1991-12-171200
K911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITORPalco Laboratories, Inc.1991-06-10840
K904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITORPalco Laboratories, Inc.1991-03-181310
K872233INJECT-EASEPalco Laboratories, Inc.1987-09-04860
K842547WET-STOPPalco Laboratories, Inc.1984-10-191090
K833344AUTO-LANCETPalco Laboratories, Inc.1983-11-07410

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