510(k) K900857
- Device
- NON STERILE PARENTERAL SUPPLY KIT
- Applicant
- INTERMED, INC.
- 510(k) number
- K900857
- Product code
- FMF
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1990-05-22
- Date received
- 1990-02-23
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- NORM RUEDT
- Address
- 15 White Lake Rd. Sparta NJ US 07871 07871
FDA Registration Numbers#
- 3005064037
- 2183771
- 1226544
- 3043603327
- 3004192065
- 2025870
- 3002806603
- 3009493875
- 8010130
- 3012302888
- 3006425876
- 3017717188
- 3013160284
- 2244771
- 3004111573
- 3043226252
- 3033589330
- 3003974574
- 9681835
- 3044994889
- 3044026004
- 2183425
- 3009107690
- 3010400367
- 3021336182
- 8031563
- 2523676
- 3011230048
- 9610825
- 1410248
- 3012116434
- 3010462274
- 3015060216
- 3007193505
- 3010384323
- 2025816
- 3036756245
- 1423625
- 9680425
- 3034676720
- 3013481097
- 3004417597
- 1219655
- 1216032
- 2029214
- 3014680149
- 3027242374
- 3003755939
- 9614033
- 3006571738
- 3036722184
- 1036836
- 3012551896
- 3016443334
- 3013023255
- 3005813632
- 1035907
- 3009746061
- 3013176080
- 1832816
- 3015309643
- 3003310007
- 3009423112
- 3010132111
- 2030624
- 3031259044
- 3043051314
- 3027339877
- 1037885
- 1043214
- 3015620563
- 3006697681
- 3016965628
- 2320767
- 3008789114
- 3008719222
- 2032112
- 3024088964
- 1047843
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026-08-26 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026-08-25 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026-08-14 |
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases