Cleared Traditional

K912650 - 1.1, 1.2, 1.3 TEMPERATURE PROBES

K912650 is an FDA 510(k) clearance for 1.1, manufactured by Vital Signs, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K912650 · Vital Signs, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
60d
Days
Class 2
Risk

K912650 is an FDA 510(k) clearance for the 1.1, 1.2, 1.3 TEMPERATURE PROBES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 60 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K912650

510(k) Number K912650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date August 16, 1991
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 577
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K912650.
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
K913082 · Respiratory Support Products, Inc. · Dec 1991
BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
K912280 · Respiratory Support Products, Inc. · Oct 1991
BI-TEMP TEMPERATURE MONITOR TM-201D
K913083 · Respiratory Support Products, Inc. · Oct 1991
TEMPERATURE WELL PROBE, TWP SERIES
K910868 · Gish Biomedical, Inc. · Apr 1991
YSI PRECISION 4000 THERMOMETER
K910718 · Yellow Springs Instrument Co., Inc. · Apr 1991
DATA RECORDER
K910118 · Healthdyne, Inc. · Feb 1991