510(k) K844792
- Device
- MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
- Applicant
- PACESETTER SYSTEMS
- 510(k) number
- K844792
- Product code
- FRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-22
- Date received
- 1984-12-10
- Regulation
- 880.5725
- Classification name
- Pump, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- NESTOR KUSNIERZ
- Address
- 12884 Bradley Ave. Sylmar CA US 91342 91342
FDA Registration Numbers#
- 1123137
- 3009754410
- 3009211636
- 3008717264
- 9611004
- 3005382983
- 2011171
- 9612030
- 1061124
- 1219602
- 3000204189
- 3012307300
- 3024706751
- 3008810357
- 1054713
- 3006158088
- 1222313
- 3010432890
- 2024022
- 3000240707
- 9610847
- 3017907746
- 1314417
- 2032862
- 2030624
- 1220973
- 3008058400
- 3003144120
- 3004548776
- 3013764800
- 3005778453
- 3016798778
- 2024064
- 3012337868
- 3011688490
- 9680425
- 9617594
- 1219702
- 1125615
- 2032227
- 3004491689
- 9614279
- 9680741
- 1928237
- 1319639
- 3008513006
- 2219920
- 3010564249
- 3002879653
- 3007939342
- 1121996
- 3042027705
- 9610825
- 9615908
- 1018470
- 3011883032
- 3006575795
- 3010273872
- 2411512
- 9710049
- 1720929
- 9615050
- 2523167
- 3007738736
- 3014732157
- 3024122953
- 1713468
- 1921846
- 3004906872
- 1423507
- 1058584
- 9612051
- 1526611
- 3003879246
- 3013557562
- 1722139
- 1416980
- 3006534321
- 2523676
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | 2026-01-28 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2025-07-28 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | 2025-07-28 |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025-05-28 |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025-04-25 |
| K242115 | Plum Duo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 |
| K242114 | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | 2025-04-02 |
| K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025-03-11 |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025-01-16 |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies | 2024-12-23 |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | 2024-10-03 |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024-09-05 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | 2024-05-17 |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | 2024-03-29 |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems | 2023-11-03 |
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