Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jms Co., Ltd. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
394 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | Jms Co., Ltd. | 2001-09-06 | 400 | 0 |
| K002394 | JMS APHERESIS NEEDLE SET ACCORDION TYPE | Jms Co., Ltd. | 2001-09-05 | 394 | 0 |
| K010406 | JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G | Jms Co., Ltd. | 2001-06-20 | 128 | 0 |
| K010410 | JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G | Jms Co., Ltd. | 2001-06-20 | 128 | 0 |
| K000843 | MODIFICATION TO JMS APHERESIS NEEDLE | Jms Co., Ltd. | 2000-04-10 | 26 | 0 |
| K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | Jms Co., Ltd. | 2000-04-10 | 26 | 0 |
| K991904 | MODIFICATION OF JMS NEEDLES AND JMS SYRINGES | Jms Co., Ltd. | 1999-08-31 | 88 | 0 |
| K990510 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1999-08-30 | 193 | 0 |
| K990470 | JMS A. V. FISTULA NEEDLE SET | Jms Co., Ltd. | 1999-08-30 | 195 | 0 |
| K983707 | JMS DIALYZER PRIMING SET | Jms Co., Ltd. | 1999-01-08 | 79 | 0 |
| K974902 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1998-03-30 | 90 | 0 |
| K970962 | JMS AV FISTULA NEEDLE | Jms Co., Ltd. | 1997-08-07 | 143 | 0 |
| K965027 | VENTED I.V. SET | Jms Co., Ltd. | 1997-06-24 | 189 | 0 |
| K915174 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1993-03-02 | 473 | 0 |
| K911199 | JMS AV FISTULA NEEDLES | Jms Co., Ltd. | 1991-08-28 | 175 | 0 |
| K895882 | JMS DIALYZER PRIMING SET | Jms Co., Ltd. | 1990-02-09 | 127 | 0 |
| K880726 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1988-03-16 | 22 | 0 |
| K880174 | JMS TRANSFUSION SET | Jms Co., Ltd. | 1988-02-16 | 32 | 0 |
| K871965 | JMS NEEDLES AND JMS SYRINGES | Jms Co., Ltd. | 1987-09-04 | 108 | 0 |
| K864747 | VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES | Jms Co., Ltd. | 1986-12-29 | 24 | 0 |
| K860789 | JMD AV FISTULA NEEDLE (MODIFICATION) | Jms Co., Ltd. | 1986-03-18 | 20 | 0 |
| K860241 | JMS AV FISTULA NEEDLE | Jms Co., Ltd. | 1986-02-05 | 12 | 0 |
| K853838 | JMS LCC INSULIN SYRINGE | Jms Co., Ltd. | 1985-10-16 | 72 | 0 |
| K845043 | JMS NEEDLES & JMS SYRINGES | Jms Co., Ltd. | 1985-04-29 | 122 | 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