Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mcneil-Ppc, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
191 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081236 | K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME | Mcneil-Ppc, Inc. | 2008-09-25 | 147 | 0 |
| K072421 | K-Y BRAND YOURS+MINE | Mcneil-Ppc, Inc. | 2008-03-06 | 191 | 0 |
| K072360 | K-Y BRAND INTRIGUE INTENSE WARMING SENSATION | Mcneil-Ppc, Inc. | 2007-12-12 | 112 | 0 |
| K062535 | K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING | Mcneil-Ppc, Inc. | 2007-01-26 | 150 | 0 |
| K053397 | K-Y BRAND SENSUAL MIST | Mcneil-Ppc, Inc. | 2006-02-17 | 73 | 0 |
| K023789 | O.B. TAMPONS | Mcneil-Ppc, Inc. | 2002-12-06 | 23 | 0 |
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