# K061996: Sandman Pocket

- Pathway: 510(k) (Traditional)
- Applicant: Eb Neuro S.P.A.
- Decided: Oct 3, 2006 after 81 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962603 (1997). 11 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990565: Suzanne, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K040595: ALICE 5, Respironics, Inc. (2004) Summary page 1.

## Most influential descendants
- K093728: BE Micro, Trea (2010), 4 descendants of its own
- K133355: Cadwell Flex Eeg/PSG (2014), 3 descendants of its own
- K180269: Cadwell Apollo System (2018), 2 descendants of its own
- K201819: Cadwell Apollo System (2020), 1 descendant of its own
- K221959: Q21 (2023), 0 descendants of its own

## Indications for use
Intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is indended for pediatric through adult patient populations, and can be used in either home or hospital environments. The Sandman Pocket is not intended for use as life supporting equipment, such as a vital sign monitoring in on intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor. The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.

Source page: https://510kreport.com/device/K061996
Methodology: https://510kreport.com/methodology