Cleared Traditional

K964286 - ZOMED PASSIVE TEMPERATURE PROBE

K964286 is an FDA 510(k) clearance for ZOMED PASSIVE TEMPERATURE PROBE, manufactured by Zomed Intl.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K964286 · Zomed Intl. · General Hospital
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Nov 1996
Decision
22d
Days
Class 2
Risk

K964286 is an FDA 510(k) clearance for the ZOMED PASSIVE TEMPERATURE PROBE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Zomed Intl. (Mountain View, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 22 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 Zomed Intl. devices

FDA 510(k) Submission Details - K964286

510(k) Number K964286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date November 19, 1996
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
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 438
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K964286.
SURETEMP
K964643 · Diatek Instruments, Inc. · Jan 1997
THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
K954523 · Thermoscan, Inc. · Dec 1996
THE SAFETY 1ST DIGITAL PACIFIER
K963276 · Safety 1st, Inc. · Dec 1996
GEON ELECTRONIC THERMOMETER
K952001 · Geon Corp. · Oct 1996
Q-TIPS, FAICHNEY, PRIVATE LABEL
K962497 · Faichney Medical Co. · Oct 1996
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846 · Y · Oct 1996