Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ludlow Technical Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
175 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 500 | Ludlow Technical Products | 1999-07-08 | 87 | 0 |
| K973110 | LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPO | Ludlow Technical Products | 1997-10-21 | 62 | 0 |
| K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | Ludlow Technical Products | 1997-08-21 | 37 | 0 |
| K964401 | KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DT | Ludlow Technical Products | 1997-02-06 | 94 | 0 |
| K931903 | SURELOCK(TM) SNAPLESS MONITORING ELECTRODE | Ludlow Technical Products | 1993-10-07 | 175 | 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