Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew, Mpl Division · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
189 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843314 | MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE | Smith & Nephew, Mpl Division | 1984-09-27 | 34 | 0 |
| K841280 | SOLOPAK BRAND FILTER NEEDLE W/5 MICRO | Smith & Nephew, Mpl Division | 1984-05-21 | 54 | 0 |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division | 1984-04-05 | 76 | 0 |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Smith & Nephew, Mpl Division | 1984-03-30 | 189 | 0 |
| K832126 | MICRO Z DISPOS. SPINAL ANESTH. NEEDLE | Smith & Nephew, Mpl Division | 1983-08-12 | 42 | 0 |
| K831765 | HERAPIN LOCK FLUSH SOLUTION USE KIT | Smith & Nephew, Mpl Division | 1983-07-12 | 41 | 0 |
| K830524 | HENKE JECT PRESSURE SYRINGE | Smith & Nephew, Mpl Division | 1983-03-24 | 35 | 0 |
| K830242 | MICRO 2 HYPODERMIC NEEDLES | Smith & Nephew, Mpl Division | 1983-02-15 | 21 | 0 |
| K761206 | INTEROSSEOUS NEEDLE | Smith & Nephew, Mpl Division | 1976-12-13 | 6 | 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