510(k) K854446
- Device
- TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
- Applicant
- TERUMO MEDICAL CORP.
- 510(k) number
- K854446
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-09
- Date received
- 1985-11-05
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HAROLD JACOBY
- Address
- 125 Blue Ball Rd. Elkton MD US 21921 21921
FDA Registration Numbers#
- 3003310007
- 3018507299
- 3003678543
- 3005609751
- 3013162291
- 3047706961
- 2029275
- 3004111573
- 3016096098
- 3009882464
- 3004122598
- 1220973
- 3004143450
- 3017509841
- 2032098
- 3006891665
- 1319211
- 3010872792
- 3003512059
- 9610993
- 8021079
- 3036978618
- 9610847
- 3004519921
- 9681572
- 3009746425
- 2024024
- 3019004087
- 3011642792
- 3020417125
- 1526611
- 9614279
- 3007007790
- 1000523114
- 1647137
- 3008733163
- 3012552122
- 3003674698
- 1061124
- 3014246639
- 3015910259
- 3017567825
- 1320894
- 2523167
- 3010515547
- 2648727
- 3008692839
- 1055236
- 3007817041
- 3024122953
- 3019807891
- 3045322464
- 8022210
- 8041145
- 3008328679
- 1000587249
- 1038185
- 3013557562
- 3010131137
- 3004735647
- 1423537
- 3015453963
- 3002806603
- 1423662
- 9611665
- 2427500
- 3008650117
- 3014162214
- 3010293992
- 2025816
- 1000595987
- 3015620563
- 3000240707
- 3005340341
- 3005934752
- 3030447506
- 3000247873
- 1018470
- 3009631669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2026-09-11 |
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | Amsino International, Inc. | 2026-05-04 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | 2025-12-04 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025-07-24 |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 |
Legacy Summary#
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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