# K860941: Disposable Heated Wire Loops 48 and 72

- Pathway: 510(k) (Traditional)
- Applicant: Intec Medical, Inc.
- Decided: Apr 2, 1986 after 21 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962220: Heated Wire Circuits  for SCT 3000 Heated Humidifier (1997), 1 descendant of its own
- K993268: Mallinckrodt Dar Heated Wire Breathing Circuit (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K860941
Methodology: https://510kreport.com/methodology