DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM— 510(k) K072921

Name: FDA 510(k) clearance K072921
Creator: U.S. Food and Drug Administration
Published: 2007-11-26

Substantially Equivalent

Symbios Medical Products, LLC

FDA 510(k) clearance K072921 for DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM, Substantially Equivalent on 2007-11-26. Applicant: Symbios Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Symbios Medical Products, LLC
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2007-10-15
Decision date: 2007-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEB

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K250234 — SMARTeZ Elastomeric Infusion Pump (RS series)2026-04-24
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K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)2024-10-07
K181360 — ON-Q* Pump with Bolus2019-03-22
K151650 — SMARTez elastomeric infusion pump2016-04-04

More clearances from Symbios Medical Products, LLC

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K071735 — MODIFICATION TO DISPOSABLE INFUSION PUMP KIT2007-07-19
K051474 — SYMBIOS DISPOSABLE INFUSION PUMP KIT2005-07-01

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K072921

K-number listed on FDA's recall record

Z-0940-2013 — GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain managementClass I·Terminated·Symbios Medical Products, LLC·20130225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072921.

Data sourced from openFDA. This site is unofficial and independent of the FDA.