# K990565: Suzanne

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Aug 18, 1999 after 177 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
No predicates in its family tree.
58 later devices descend from it; 3 cite it directly.
0 of 59 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 its predicate without a number.
- (no number) Nellcor Puritan Bennett SleepWizard: named in the summary without a submission number

## Most influential descendants
- K031202: Medipalm-20 (2003), 48 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K122516: Embletta MPR (2013), 27 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own

## Indications for use
The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

Source page: https://510kreport.com/device/K990565
Methodology: https://510kreport.com/methodology