PRESS-MATE PM-2100 VITAL SIGN MONITOR— 510(k) K022537

Name: FDA 510(k) clearance K022537
Creator: U.S. Food and Drug Administration
Published: 2002-09-13

Substantially Equivalent

Colin Medical Instruments Corp.

FDA 510(k) clearance K022537 for PRESS-MATE PM-2100 VITAL SIGN MONITOR, Substantially Equivalent on 2002-09-13. Applicant: Colin Medical Instruments Corp.. Device class: 2.

Clearance details

Applicant: Colin Medical Instruments Corp.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2002-08-01
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWI

view all

K260438 — Vital Signs Monitor (CLEO2)2026-08-14
K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Colin Medical Instruments Corp.

view all

K032857 — PRESS-MATE BX-10 VITAL SIGN MONITOR2004-02-04
K973637 — PRESS-MATE ADVANTAGE1998-09-25
K922668 — PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM1997-01-29
K942871 — PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM1994-10-17
K921048 — BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST1993-07-01

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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 →

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