# K050883: Safersleep System

- Pathway: 510(k) (Traditional)
- Applicant: Safer Sleep, LLC
- Decided: Nov 4, 2005 after 211 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: 4 generations back to K904518 (1990). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030939: Philips Compurecord Peri-Operative Information System Software, Philips Medical Systems (2003) Summary page 1.
- K041241: Medley System with Bar Code Module, Model 8600, Alaris Medical Systems, Inc. (2004) Summary page 4.

## Most influential descendants
- K062388: Anesthesia Information and Digital-Drug Management System (2007), 5 descendants of its own
- K141474: Becton Dickinson Intelliport System (2014), 2 descendants of its own
- K182092: BD Intelliport System (2019), 1 descendant of its own
- K101439: Codonics Safe Labeling System (SLS), Model 500I/500P (2011), 1 descendant of its own
- K251352: Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (2025), 0 descendants of its own

## Indications for use
The SAFERsteep System is a software-based product intended for use by an anesthetist to assist in the safe administration and record keeping of drugs used during an anesthetic procedure. The SAFERsleep System provides an integrated method of information collection and documentation on drugs administered and concurrent anesthetic monitor data. The system also includes ease of use features to reduce the possibility of errors in drug administration.

Source page: https://510kreport.com/device/K050883
Methodology: https://510kreport.com/methodology