510(k) K913498
- Device
- MX927 BLOOD TRANSFER DEVICE
- Applicant
- MEDEX, INC.
- 510(k) number
- K913498
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-11-27
- Date received
- 1991-08-06
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CATHY CHENETSKI
- Address
- 3637 Lacon Rd. Hilliard OH US 43026 43026
FDA Registration Numbers#
- 1043646
- 1722458
- 3027332508
- 9616791
- 1820334
- 3015142721
- 3010872792
- 3007007790
- 3013557562
- 3021286079
- 9612086
- 3006082230
- 3007392007
- 3010392991
- 3009498548
- 3014315664
- 3008789114
- 3012050423
- 3008588205
- 3014662855
- 3010384323
- 1423507
- 2011171
- 3002682307
- 3045891669
- 1036836
- 3008272066
- 3016884191
- 3003348846
- 9613304
- 1450392
- 1928237
- 2031093
- 1055927
- 1217831
- 1450743
- 9611680
- 3006973666
- 1417485
- 3010830834
- 3005202235
- 3012116434
- 3013298431
- 1030451
- 3015042030
- 3003824562
- 3007097064
- 3018094310
- 3012646696
- 3003464075
- 3023359743
- 3004416208
- 3022699058
- 3035642068
- 1063851
- 3010515547
- 9611446
- 1222780
- 9681835
- 3008381300
- 3008729549
- 3018125942
- 3034669683
- 2020394
- 3023339256
- 3009761558
- 1034525
- 1018233
- 3015058854
- 3013160284
- 3017654330
- 3027338968
- 3014747754
- 9616074
- 3019944216
- 3044026004
- 9612501
- 3006450239
- 1220905
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | 2026-08-10 |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 |
| K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026-07-29 |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 |
| K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| K253047 | PRESSONE™ | Nipro Medical Corporation | 2026-03-24 |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| K252886 | Pen Needle | Hh Global Technology, Inc. | 2026-01-06 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 |
| K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025-07-24 |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025-07-08 |
Legacy Summary#
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FDA Review#
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