Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Luther Medical Products, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
474 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982797 | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, P | Luther Medical Products, Inc. | 1998-11-30 | 112 | 0 |
| K980090 | ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60 | Luther Medical Products, Inc. | 1998-03-24 | 74 | 0 |
| K974543 | L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHA | Luther Medical Products, Inc. | 1998-02-10 | 69 | 0 |
| K940198 | L-CATH CONNECTOR ASSEMBLY | Luther Medical Products, Inc. | 1994-12-15 | 336 | 0 |
| K942103 | L-CATH CATHETER SYSTEM - PORT L-CATH | Luther Medical Products, Inc. | 1994-07-26 | 85 | 0 |
| K930473 | ONECATH L-CATH CATHETER SYSTEM | Luther Medical Products, Inc. | 1994-04-07 | 434 | 0 |
| K925236 | L CATH(R) CATHETER SYSTEM | Luther Medical Products, Inc. | 1994-03-22 | 522 | 0 |
| K920755 | L-CATH PEEL AWAY SYSTEM CATHETER | Luther Medical Products, Inc. | 1993-06-07 | 474 | 10 |
| K925979 | DUAL LUMEN L-CATH CATHETER SYSTEM | Luther Medical Products, Inc. | 1993-05-27 | 183 | 0 |
| K924968 | L-CATH PEEL-AWAY CATHETER SYSTEM | Luther Medical Products, Inc. | 1993-05-21 | 233 | 0 |
| K924562 | CATHETER INTRODUCER | Luther Medical Products, Inc. | 1993-02-25 | 169 | 0 |
| K884806 | LUMED EXPANDO-CATH, ACTIV | Luther Medical Products, Inc. | 1989-02-08 | 83 | 0 |
| K871546 | SAFESIDE(TM) LUMED | Luther Medical Products, Inc. | 1987-06-17 | 58 | 0 |
| K853348 | L-CATH EXPANDO CATH | Luther Medical Products, Inc. | 1986-01-09 | 150 | 0 |
| K822217 | THERMOTHERAPY | Luther Medical Products, Inc. | 1982-09-24 | 60 | 0 |
| K820102 | SUBCLAVIAN JUGULAR CATHETER SET | Luther Medical Products, Inc. | 1982-01-29 | 14 | 0 |
| K801575 | L-CATH INTRAVENOUS PLACEMENT UNIT | Luther Medical Products, Inc. | 1980-08-20 | 43 | 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