Atlas FDA

TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP

FDA 510(k) clearance K900585 · decided 1990-04-18

Clearance details

K-number
K900585
Device name
TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
Applicant
Baxa Corp., Sub. of Cook Group, Inc.
Decision
Substantially Equivalent
Date received
1990-02-07
Decision date
1990-04-18
Days to decision
70 days
Clearance type
Traditional
Product code
LHI
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Englewood, CO, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxa Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
ADRx™ Admixture Device (K252987)Epic Medical Pte. , Ltd.2026-06-12
Vial Adapter (K260301)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-06-05
Medline Bag Decanter (K250345)Medline Industries, LP2025-10-24
FlowArt® Vial Access Device Vented (K251715)Asset Medikal2025-10-14
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (K251676)Microtek Medical, LLC2025-09-16
HyHub™ and HyHub™ Duo Vial Access Devices (K243404)Takeda Pharmaceuticals2025-07-18
Arisure® Closed Male Luer with Spike Adapter (YM060) (K240761)Yukon Medical, LLC2025-03-21
Rio™ Drug Reconstitution Transfer Device (K243985)Icu Medical, Inc.2025-01-22
SmartSiteTM Vented Vial Access Device (K243486)Yukon Medical, LLC2024-12-06
nextaro® va, 15mm, 5µm (K241976)Sfm Medical Devices GmbH2024-09-06
Vent Vial Adapter (K233287)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-07-26
FlowArt Valve for Vial Access (K232987)Asset Medikal Tasarim Sanayi VE Ticaret A.S.2024-06-26

Recalls involving this device

RecordFirmDate
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-vo recall (Z-0363-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large- recall (Z-0364-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-v recall (Z-0365-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-v recall (Z-0366-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-v recall (Z-0367-2019)Baxter Healthcare Corporation2018-11-02
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulat recall (Z-0007-2017)Baxter Corporation Englewood2016-10-06
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Pro recall (Z-2165-2013)Baxa Corporation2013-09-06
Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand recall (Z-1420-2012)Baxa Corporation2012-04-13
ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood recall (Z-1962-2011)Baxa Corporation2011-04-12
ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112 recall (Z-1963-2011)Baxa Corporation2011-04-12
ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO 80112 recall (Z-1964-2011)Baxa Corporation2011-04-12
ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 8011 recall (Z-1965-2011)Baxa Corporation2011-04-12
ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 8011 recall (Z-1966-2011)Baxa Corporation2011-04-12
ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 8011 recall (Z-1967-2011)Baxa Corporation2011-04-12
Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation. recall (Z-2137-2010)Baxa Corporation2010-08-02
Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation. recall (Z-2138-2010)Baxa Corporation2010-08-02
Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation. recall (Z-2139-2010)Baxa Corporation2010-08-02
Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation. recall (Z-2140-2010)Baxa Corporation2010-08-02
Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation. recall (Z-2141-2010)Baxa Corporation2010-08-02
Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation. recall (Z-2142-2010)Baxa Corporation2010-08-02
Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation. recall (Z-2143-2010)Baxa Corporation2010-08-02
Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Orde recall (Z-2144-2010)Baxa Corporation2010-08-02
Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 3 recall (Z-2145-2010)Baxa Corporation2010-08-02
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, B recall (Z-2146-2010)Baxa Corporation2010-08-02
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Ster recall (Z-2147-2010)Baxa Corporation2010-08-02
Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and recall (Z-2148-2010)Baxa Corporation2010-08-02
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation. recall (Z-1030-2010)Baxa Corporation2010-03-09
Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation recall (Z-1031-2010)Baxa Corporation2010-03-09
Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation recall (Z-1032-2010)Baxa Corporation2010-03-09
Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube recall (Z-0978-04)Baxa Corporation2004-07-20
Exacta-Mix Valve Set, Secondary Valve Assembly recall (Z-0979-04)Baxa Corporation2004-07-20
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled recall (Z-0980-04)Baxa Corporation2004-07-20
Exacta-Mix Valve Set, Six Inlet, Tubing Kit recall (Z-0981-04)Baxa Corporation2004-07-20
Exacta-Mix Valve Set, Primary Valve Assembly recall (Z-0982-04)Baxa Corporation2004-07-20
Exacta-Mix Valve Set, Primary Valve Assembly, Pediatric recall (Z-0983-04)Baxa Corporation2004-07-20
Exacta-Mix Valve Set, Primary Valve Assembly recall (Z-0984-04)Baxa Corporation2004-07-20