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510(k) K012451

PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 by Welch Allyn Protocol, Inc. — Product Code DRT

K012451 is an FDA 510(k) premarket notification submitted by Welch Allyn Protocol, Inc. for the device "PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246". The FDA issued a decision of Substantially Equivalent on August 20, 2001. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Welch Allyn Protocol, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2001
Date Received
August 1, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Welch Allyn Protocol, Inc.

  • K070204 — LINK TO ACUITY CLINICIAN NOTIFIER (March 23, 2007)
  • K063419 — MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (December 4, 2006)
  • K033378 — VITAL SIGNS MONITOR, PROPAQ LT (March 1, 2004)
  • K031740 — VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES (August 26, 2003)
  • K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (August 21, 2002)
  • K021681 — MICROPAQ, MODELS 402, 404 (July 23, 2002)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources