Cleared Traditional

K861771 - META - HEALTH MODEL MTG III

K861771 is an FDA 510(k) clearance for META - HEALTH MODEL MTG III, manufactured by Meta Health, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K861771 · Meta Health, Inc. · General Hospital
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Jun 1986
Decision
54d
Days
Class 2
Risk

K861771 is an FDA 510(k) clearance for the META - HEALTH MODEL MTG III. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Meta Health, Inc. (Richmond, US). The FDA issued a Cleared decision on June 30, 1986 after a review of 54 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.

FDA 510(k) Submission Details - K861771

510(k) Number K861771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1986
Decision Date June 30, 1986
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 715
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K861771.
ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T
K864044 · Respiratory Support Products, Inc. · Nov 1986
MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER
K861623 · Luxtron · Aug 1986
(MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
K862333 · Sharp Electronics Corp. · Jul 1986
ISO-THERMEX
K861100 · Columbus Instruments Intl. Corp. · May 1986
MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL
K861473 · Radio Shack Div. Tandy Corp. · May 1986
TIGER'S DIGITAL THERMOMETER
K854349 · Tiger Electronics, Inc. · Apr 1986
K861771 · META - HEALTH MODEL MTG III
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