Welch Allyn Protocol, Inc.

• DRT — Cardiovascular2 devices
• MWI — Cardiovascular2 devices
• DQA — Cardiovascular1 device
• DSI — Cardiovascular1 device
• MSX — Cardiovascular1 device

• Z-0633-2014 — The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.Class II·Terminated·2013-11-21

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K070204 — LINK TO ACUITY CLINICIAN NOTIFIERCode MSX·2007-03-23
• K063419 — MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )Code MWI·2006-12-04
• K033378 — VITAL SIGNS MONITOR, PROPAQ LTCode MWI·2004-03-01
• K031740 — VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIESCode DQA·2003-08-26
• K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEMCode DSI·2002-08-21
• K021681 — MICROPAQ, MODELS 402, 404Code DRT·2002-07-23
• K012451 — PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246Code DRT·2001-08-20