510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983406Substantially Equivalent

Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for

Banta Healthcare Group, Ltd., Neenah WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983406 is the FDA 510(k) clearance record for SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR, a class II device, cleared for Banta Healthcare Group, Ltd. on under FDA product code FLL (Continuous Measurement Thermometer). FDA's definition for product code FLL reads: "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...". FDA records list 2 510(k) clearances for Banta Healthcare Group, Ltd., from to . As of , FDA records show no recalls naming K983406.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FLL Continuous Measurement Thermometer
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Applicant
Banta Healthcare Group, Ltd. 570 Enterprise Dr., Neenah WI
510(k) summary
Summary
Third party review
No

Clearances, product code FLL

Trailing 12 months
2 clearances under product code FLL in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260