Cleared Traditional

K897118 - SATELLITE A BLOOD ACETAMINOPHEN MONITOR...

K897118 is the FDA 510(k) clearance for SATELLITE A BLOOD ACETAMINOPHEN MONITOR... by Medisense, Inc.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K897118 · Medisense, Inc. · Toxicology device
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May 1990
Decision
135d
Days
Class 2
Risk

K897118 is an FDA 510(k) clearance for the SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Medisense, Inc. (Cambridge, US). The FDA issued a Cleared decision on May 10, 1990 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medisense, Inc. devices

Submission Details

510(k) Number K897118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date May 10, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 87d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 28
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K897118.
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1989
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · Em Diagnostic Systems, Inc. · Aug 1988
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · Stanbio Laboratory · Apr 1985