TRACE MODEL# 840, 841,842 & 845 ARM BOARD— 510(k) K925502

Name: FDA 510(k) clearance K925502
Creator: U.S. Food and Drug Administration
Published: 1993-01-12

Substantially Equivalent

Trace Medical Equipment, Inc.

FDA 510(k) clearance K925502 for TRACE MODEL# 840, 841,842 & 845 ARM BOARD, Substantially Equivalent on 1993-01-12. Applicant: Trace Medical Equipment, Inc.. Device class: 1.

Clearance details

Applicant: Trace Medical Equipment, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1992-10-30
Decision date: 1993-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMK

view all

K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F2019-07-09
K981860 — A P HARNESS1999-06-03
K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

More clearances from Trace Medical Equipment, Inc.

view all

K925145 — TRACE MODEL #'S 840, 841, 842, 8451993-05-19

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.