Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Menlo Care, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
243 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | Menlo Care, Inc. | 1997-04-16 | 161 | 0 |
| K951620 | MIDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1996-04-04 | 363 | 0 |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHET | Menlo Care, Inc. | 1995-04-06 | 147 | 0 |
| K944968 | LANDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1995-03-29 | 169 | 0 |
| K950737 | LANDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1995-03-29 | 41 | 0 |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | Menlo Care, Inc. | 1995-03-07 | 210 | 0 |
| K943143 | BILIARY STENT | Menlo Care, Inc. | 1995-02-28 | 243 | 0 |
| K930048 | SAFE-PICC CATHETER | Menlo Care, Inc. | 1994-05-12 | 492 | 0 |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Menlo Care, Inc. | 1994-03-31 | 231 | 0 |
| K940127 | CENTERMARK SECURING WINGS | Menlo Care, Inc. | 1994-02-09 | 30 | 0 |
| K923394 | MENLO CARE AQUASTENT SET | Menlo Care, Inc. | 1993-11-16 | 494 | 0 |
| K930801 | INTROPEEL | Menlo Care, Inc. | 1993-09-22 | 218 | 0 |
| K931218 | INTROPEEL V | Menlo Care, Inc. | 1993-09-22 | 196 | 0 |
| K920828 | SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT | Menlo Care, Inc. | 1992-08-14 | 172 | 0 |
| K920128 | VERSACATH MAINLINE CENTRAL VENOUS CATHETER | Menlo Care, Inc. | 1992-03-26 | 73 | 0 |
| K920133 | VERSACATH SELECTALUMEN INNER CATHETER | Menlo Care, Inc. | 1992-03-26 | 73 | 0 |
| K920028 | LANDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1992-03-26 | 83 | 0 |
| K912358 | LANDMARK ADD-A-LUMEN CATHETER KIT | Menlo Care, Inc. | 1992-01-02 | 219 | 0 |
| K912165 | LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM | Menlo Care, Inc. | 1991-12-11 | 209 | 0 |
| K910566 | VERSACATH(TM) MULTILUMEN SYSTEM | Menlo Care, Inc. | 1991-06-03 | 115 | 0 |
| K910565 | VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY | Menlo Care, Inc. | 1991-06-03 | 115 | 0 |
| K910564 | VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY | Menlo Care, Inc. | 1991-05-06 | 87 | 0 |
| K910799 | LANDMARK VENOUS ACCESS DEVICE | Menlo Care, Inc. | 1991-03-21 | 24 | 0 |
| K901374 | CENTREMARK(TM) CENTRAL VENOUS CATHETER TRAY | Menlo Care, Inc. | 1990-06-26 | 96 | 0 |
| K896774 | STREAMLINE VASCULAR ACCESS DEVICE | Menlo Care, Inc. | 1989-12-27 | 26 | 0 |
| K883980 | LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES) | Menlo Care, Inc. | 1988-12-05 | 75 | 0 |
| K883866 | NEOSOFT UMBILICAL VESSEL CATHETER | Menlo Care, Inc. | 1988-11-21 | 69 | 0 |
| K884259 | MODIFIED LANDMARK VENOUS ACCESS DEVICE | Menlo Care, Inc. | 1988-11-01 | 28 | 0 |
| K882242 | LANDMARK(TM) VENOUS ACCESS DEVICE | Menlo Care, Inc. | 1988-06-20 | 31 | 0 |
| K862130 | COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. | Menlo Care, Inc. | 1986-08-14 | 71 | 0 |
| K860474 | STREAM LINE* I.V. CATHETER PLACEMENT UNIT | Menlo Care, Inc. | 1986-05-06 | 88 | 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