# K934599: Sandman

- Pathway: 510(k) (Traditional)
- Applicant: Melville Software, Ltd.
- Decided: Jan 27, 1994 after 125 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012437: Devilbiss Sleep Recorder Model # RM60 (2002), 42 descendants of its own
- K040595: ALICE 5 (2004), 40 descendants of its own
- K112102: Michele Sleep Scoring Systems (2011), 18 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own
- K130007: Sleep Profiler (2013), 14 descendants of its own

## Indications for use
The SANDMAN device is used solely for the collection, storage and display of data either: a) collected by SANDMAN from FDA approved equipment that requires no modification to support this function, or b) input by the qualified technologist.

Source page: https://510kreport.com/device/K934599
Methodology: https://510kreport.com/methodology