Cleared Traditional

K881286 - TEMPA-DOT CLINICAL THERMOMETER SHEATH

K881286 is an FDA 510(k) clearance for TEMPA-DOT CLINICAL THERMOMETER SHEATH, manufactured by Pymah Corp.. The device is a Class 1 General Hospital device with product code FQZ cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K881286 · Pymah Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
75d
Days
Class 1
Risk

K881286 is an FDA 510(k) clearance for the TEMPA-DOT CLINICAL THERMOMETER SHEATH. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Pymah Corp. (Somerville, US). The FDA issued a Cleared decision on June 8, 1988 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2900 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K881286

510(k) Number K881286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1988
Decision Date June 08, 1988
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

FQZ Device Classification - Class 1, General Controls

Product Code FQZ Thermometer, Clinical Color Change
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQZ Thermometer, Clinical Color Change

All 13
Devices cleared under the same product code (FQZ) and FDA review panel - the closest regulatory comparables to K881286.
DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP
K946046 · Deroyal Critical Care, Div. Deroyal Technologies · Jul 1995
POINT CHECKER COLOR STRIP THERMOMETER
K894893 · Kyowa Medex Co., Ltd. · Apr 1990
FRANKLIN COLLECTOR(R)
K884612 · Franklin Diagnostics, Inc. · Mar 1989
HEALTHCHECK THERM-STRIP
K863181 · Healthcheck Corp. · Sep 1986
PEE WEE THERMOMETERS
K853515 · Joel R.L. Ehren Kranz · Oct 1985
BABY TEMP PACIFIER
K822423 · Trp Energy Sensors, Inc. · Oct 1982
K881286 · TEMPA-DOT CLINICAL THERMOMETER SHEATH
Download PDF Pymah Corp.