510(k) K153388
- Device
- IMPROSAFE Blood Collection Set With Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback
- Applicant
- GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.
- 510(k) number
- K153388
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-07
- Date received
- 2015-11-23
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BANGFU SUN
- Address
- # 102, Kaiyuan Ave., Science City Guangzhou Eco & Tech Dev District Guangzhou CN 510530 510530
FDA Registration Numbers#
- 3004416208
- 2523676
- 3007344957
- 3003902955
- 3010621964
- 3005798905
- 3008272066
- 9611680
- 3034669683
- 1836161
- 3010384323
- 3038356900
- 3015485283
- 1035907
- 1710034
- 3010864832
- 3008780388
- 3023316
- 3005246939
- 1820334
- 3008729549
- 1000118068
- 3007617202
- 3043531632
- 3009504230
- 3010419931
- 8020040
- 3012050423
- 3016904853
- 3004054016
- 3020831613
- 3004468406
- 3020138744
- 3012039263
- 8041187
- 3019004087
- 3002807408
- 3031233007
- 1054241
- 1036836
- 3009888344
- 3010026090
- 3006371704
- 1647137
- 3021186226
- 1018470
- 3003915875
- 1018233
- 3014315664
- 1644312
- 8010026
- 1034525
- 1222780
- 1832816
- 3009518015
- 8021764
- 3010041511
- 2183744
- 2025816
- 3011198121
- 3009756153
- 1047429
- 1224960
- 3012421607
- 3010413216
- 3005674478
- 3013160357
- 3024508819
- 3008009298
- 3018125942
- 3004425647
- 3005654106
- 3007817041
- 3004111573
- 1423507
- 3008998256
- 3023228837
- 9612030
- 3019944216
Source Documents#
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025-05-29 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025-04-04 |
Legacy Summary#
summary
FDA Review#
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