Home / 510(k) Clearances / K910852

510(k) K910852

507 NON-INVASIVE VITAL SIGNS MONITOR by Criticare Systems, Inc. — Product Code DRT

K910852 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "507 NON-INVASIVE VITAL SIGNS MONITOR". The FDA issued a decision of Substantially Equivalent on Jul 30, 1991. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Criticare Systems, Inc. has 21 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 30, 1991
Date Received
Feb 27, 1991
Clearance Type
Traditional
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
510(k)

Other clearances by Criticare Systems, Inc.

  • K101602 — VITAL SIGNS MONITOR (Sep 1, 2010)
  • K091050 — 506CN PATIENT MONITOR (May 27, 2009)
  • K042569 — 8600 VITAL SIGNS MONITOR (Sep 29, 2004)
  • K030613 — VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 (Apr 17, 2003)
  • K022435 — 507EL VITAL SIGNS MONITOR (Aug 14, 2002)
  • K012059 — 8100/8500 VITAL SIGNS MONITOR (Aug 1, 2001)
  • K001020 — 8100 VITAL SIGNS MONITOR (Apr 28, 2000)
  • K000276 — MPT 24 AND VITAL VIEW 24 (Mar 1, 2000)
  • K961223 — MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS (Dec 10, 1996)
  • K944860 — SCHOLAR PATIENT MONITOR (Jun 20, 1995)

Other clearances for product code DRT

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

FDA data resources