Cleared Traditional

K910118 - DATA RECORDER

K910118 is an FDA 510(k) clearance for DATA RECORDER, manufactured by Healthdyne, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K910118 · Healthdyne, Inc. · General Hospital
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Feb 1991
Decision
34d
Days
Class 2
Risk

K910118 is an FDA 510(k) clearance for the DATA RECORDER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Snellville, US). The FDA issued a Cleared decision on February 14, 1991 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - 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.

View all Healthdyne, Inc. devices

FDA 510(k) Submission Details - K910118

510(k) Number K910118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1991
Decision Date February 14, 1991
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
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 General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 398
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K910118.
1.1, 1.2, 1.3 TEMPERATURE PROBES
K912650 · Vital Signs, Inc. · Aug 1991
TEMPERATURE WELL PROBE, TWP SERIES
K910868 · Gish Biomedical, Inc. · Apr 1991
YSI PRECISION 4000 THERMOMETER
K910718 · Yellow Springs Instrument Co., Inc. · Apr 1991
DIGITAL THERMOMETER KITS
K905025 · Abco Dealers, Inc. · Feb 1991
KEJUMP DIGITAL CLINICAL THERMOMETER
K903590 · K-Jump Health Co., Ltd. · Oct 1990
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990