Atlas FDA

VOLUMETRIC INFUSION PUMP

FDA 510(k) clearance K904518 · decided 1990-10-17

Clearance details

K-number
K904518
Device name
VOLUMETRIC INFUSION PUMP
Applicant
Kendall Mcgaw Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1990-10-03
Decision date
1990-10-17
Days to decision
14 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703)Deka R&D Corp2026-07-24
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015)Koru Medical Systems, Inc.2026-01-28
SIGMA Spectrum Infusion Pump with Master Drug Library (K251640)Baxter Healthcare Corporation2025-07-28
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636)Baxter Healthcare Corporation2025-07-28
MRidium 3870 MRI Infusion Pump System (3870) (K242752)Iradimed Corporation2025-05-28
BD Alaris Infusion System with Guardrails Suite MX (K243855)Carefusion 303, Inc.2025-04-25
Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
Plum Duo™ Precision IV Pump (K242115)Icu Medical, Inc.2025-04-02
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357)Deka Research & Development Corp.2025-03-11
Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736)Deka Research and Development Corp.2025-01-16
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735)Belmont Medical Technologies2024-12-23
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660)Zevex, Inc.2024-10-03

Recalls involving this device

RecordFirmDate
Outlook Safety Infusion System Burette Set. For intravenous fluid administration. recall (Z-2166-2013)B. Braun Medical, Inc.2013-09-06
Outlook Pump Add On Set with Ultrasite Injection Site Spin Lock Connector 88 in US3110 recall (Z-0675-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Injection Site 0.2um Filter Spin Lock Connector 115 recall (Z-0676-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Site recall (Z-0679-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Site recall (Z-0680-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites recall (Z-0681-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 recall (Z-0682-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeli recall (Z-0683-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set with Universal Spike and Spin Lock Connector 133 in 1500HP recall (Z-0687-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Supor Membrane 1.2um Filter, Spin Lock Connector 12 recall (Z-0688-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike & Spin Lock Connector 118 in V1500HP recall (Z-0689-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 1 Safeline & 3 Ultrasite Inj Sites, Check Valve, B/ recall (Z-0690-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Sp recall (Z-0691-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike Pressure Limited Check Valve, 2 B/C Valves, 3 Ultras recall (Z-0692-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Back Check Valve, Ultrasite Inj Site, Spin Lock Con recall (Z-0693-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connect recall (Z-0694-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C recall (Z-0697-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Check Valve, 5 Ultrasite Inj Sites, Ultraport HF St recall (Z-0698-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Lim recall (Z-0703-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Lim recall (Z-0709-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Add On Set with Injection Site & Spin Lock Connector, 90 in recall (Z-0710-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site, Spin Lock Connector, 8 recall (Z-0711-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Add On Set for Epidural Administration w/Microbore tubing & Sliding Spin Lock recall (Z-0712-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock Connector, 132 in recall (Z-0713-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set with Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin recall (Z-0714-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Loc recall (Z-0715-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock Connector, 135 in recall (Z-0716-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore Tubing, Spin Lock Conn recall (Z-0717-2010)B. Braun Medical, Inc.2010-01-26
Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited recall (Z-1428-2009)B. Braun Medical, Inc.2009-06-05
Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Inj recall (Z-1431-2009)B. Braun Medical, Inc.2009-06-05
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj s recall (Z-2407-2008)B. Braun Medical, Inc.2008-09-23
Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product recall (Z-2408-2008)B. Braun Medical, Inc.2008-09-23
Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The recall (Z-2409-2008)B. Braun Medical, Inc.2008-09-23
Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The p recall (Z-2410-2008)B. Braun Medical, Inc.2008-09-23
Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. recall (Z-0818-2007)B. Braun Medical, Inc.2007-05-31
Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. recall (Z-0819-2007)B. Braun Medical, Inc.2007-05-31