# K140264: MADM

- Pathway: 510(k) (Traditional)
- Applicant: Thornhill Research, Inc.
- Decided: Jan 5, 2015 after 336 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935370 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850648: Ohmeda Pac Portable Anesthesia System, Ohmeda Medical (1985) Summary page 5.
- K002343: Sigma Delta, Penlon, Ltd. (2001) Summary page 5.
- K000275: Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia, Datex-Ohmeda, Inc. (2000) Summary page 5.
- K123043: Irma C02 Model 200101; Irma AX 200601, Phasein AB (2012) Summary page 5.

## Indications for use
MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit. MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases. The intended patient population is adults who weigh more than 40 kg.

Source page: https://510kreport.com/device/K140264
Methodology: https://510kreport.com/methodology