Cleared Traditional

K864397 - DISPOSABLE PHARMASEAL TEMPERATURE MONIT...

K864397 is an FDA 510(k) clearance for DISPOSABLE PHARMASEAL TEMPERATURE MONIT..., manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K864397 · American Pharmaseal Div. Ahsc · General Hospital
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Dec 1986
Decision
25d
Days
Class 2
Risk

K864397 is an FDA 510(k) clearance for the DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 25 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K864397

510(k) Number K864397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1986
Decision Date December 01, 1986
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 362
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K864397.
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404 · Mallinckrodt Critical Care · Nov 1987
THERMOCOUPLE ADAPTER
K873833 · Mallinckrodt Critical Care · Nov 1987
THERMOMETER SHEATHS
K871465 · Abco Dealers, Inc. · May 1987
ESOPHAGEAL RECTAL TEMPERATURE PROBE
K863646 · Respiratory Support Products, Inc. · Nov 1986
SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T
K864195 · Respiratory Support Products, Inc. · Nov 1986
ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T
K864044 · Respiratory Support Products, Inc. · Nov 1986