FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
JMS NEEDLES & JMS SYRINGES
K Number: K845043
·
Decision Apr 29, 1985
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
24
Review Days
122
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JMS NEEDLES & JMS SYRINGES
- K Number
- K845043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Jms Co., Ltd.
- Date Received
- December 28, 1984
- Decision Date
- April 29, 1985
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Verisafe Safety Sterile Needles (SSN)
FDA 510(k)
FDA Class 2
·General Hospital
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PRESSONE
FDA 510(k)
FDA Class 2
·General Hospital
Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Jms Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | Sep 6, 2001 | Substantially Equivalent |
| K002394 | JMS APHERESIS NEEDLE SET ACCORDION TYPE | Sep 5, 2001 | Substantially Equivalent |
| K010406 | JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G | Jun 20, 2001 | Substantially Equivalent |
| K010410 | JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G | Jun 20, 2001 | Substantially Equivalent |
| K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | Apr 10, 2000 | Substantially Equivalent |
| K000843 | MODIFICATION TO JMS APHERESIS NEEDLE | Apr 10, 2000 | Substantially Equivalent |
| K991904 | MODIFICATION OF JMS NEEDLES AND JMS SYRINGES | Aug 31, 1999 | Substantially Equivalent |
| K990470 | JMS A. V. FISTULA NEEDLE SET | Aug 30, 1999 | Substantially Equivalent |
| K990510 | JMS APHERESIS NEEDLE | Aug 30, 1999 | Substantially Equivalent |
| K983707 | JMS DIALYZER PRIMING SET | Jan 8, 1999 | Substantially Equivalent |