# K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for

- Pathway: 510(k) (Traditional)
- Applicant: Banta Healthcare Group, Ltd.
- Decided: Oct 19, 1998 after 21 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871465 (1987). 1 ancestor in all.
12 later devices descend from it; 7 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871465: Thermometer Sheaths, Abco Dealers, Inc. (1987) Summary page 2.

## Cited in the summary but kept off the family tree
- K772385: Thin-Bladed Nasal Speculum, Edward Weck, Inc. (1978). Our OCR of the scanned summary read K772385, FDA’s number for Thin-Bladed Nasal Speculum (Edward Weck, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Medline Industries, Inc.”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K061007: Good Medy,  Disposable Thermometer Sheaths (2006), 5 descendants of its own
- K102508: YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 (2011), 2 descendants of its own
- K183431: Medline Digital Rectal Thermometer Sheath (2019), 1 descendant of its own
- K112289: Disposable Thermometer Covers and Sheaths (2011), 1 descendant of its own
- K063418: Acon Digital Thermometer Probe Covers (2007), 1 descendant of its own

## Indications for use
These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers, These sheaths are non-sterile and are Intended for single patlent use only.

Source page: https://510kreport.com/device/K983406
Methodology: https://510kreport.com/methodology