DripAssist Plus

FDA 510(k) K172242 · Shift Labs, Inc.

Substantially Equivalent

510(k) numberK172242

Submission

Device name
DripAssist Plus
Applicant
Shift Labs, Inc.
Seattle, WA, US
Received
July 26, 2017
Decision date
May 25, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLN – Monitor, Electric For Gravity Flow Infusion Systems
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2420
Specialty
General Hospital

Other 510(k)s with product code FLN

510(k)DeviceApplicantDecision
K150687DripAssistFLN · Traditional Shift Labs10/13/2015SE
K133870Fluid Level MonitorFLN · Traditional Coleman Laboratories04/24/2014SE
K080704Low Fluid AlarmFLN · Abbreviated Em-Tec GmbH04/17/2008SE
K050783Issys Drug Flow MonitorFLN · Traditional Integrated Sensing Systems, Inc.02/22/2006SE
K060123Levelert II Fluid Level SensorFLN · Special Smith & Nephew, Inc.02/14/2006SE
K030136Drip AlertFLN · Traditional Drip Alert, Inc.04/07/2003SE
K022248Stryker L3 HydrolertFLN · Traditional Stryker Endoscopy08/06/2002SE
K013121MT Alert Infusion MonitorFLN · Traditional Sierra Biosearch, Inc.10/15/2001SE
K973025Fluid Centurion (4-100-00)FLN · Traditional Northgate Technologies, Inc.11/20/1997SE
K972084Alexander Manufacturing Co. Rechargeable Battery Part Number M212FLN · Traditional Alexander Mfg. Co.07/03/1997SE

More from Alexander Mfg. Co.

510(k)DeviceDecision
K150687DripAssistFLN · Traditional 10/13/2015SE

Questions and answers

When was DripAssist Plus cleared by the FDA?

DripAssist Plus (K172242) received a 510(k) decision of Substantially Equivalent on May 25, 2018, 303 days after the submission was received.

What is the product code of K172242?

The FDA product code is FLN – Monitor, Electric For Gravity Flow Infusion Systems, a Class II (moderate risk) device regulated under 21 CFR 880.2420.