# K101439: Codonics Safe Labeling System (SLS), Model 500I/500P

- Pathway: 510(k) (Traditional)
- Applicant: Codonics, Inc.
- Decided: Feb 7, 2011 after 259 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: 6 generations back to K904518 (1990). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041241: Medley System with Bar Code Module, Model 8600, Alaris Medical Systems, Inc. (2004) Summary page 1.
- K050883: Safersleep System, Safer Sleep, LLC (2005) Summary page 1.
- K062388: Anesthesia Information and Digital-Drug Management System, Docusys (2007) Summary page 1.
- K030939: Philips Compurecord Peri-Operative Information System Software, Philips Medical Systems (2003) Summary page 1.

## Most influential descendants
- 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 Codonics Safe Label System (SLS) and SLS Software provides a simple computer-based bar code scanning & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes, and to print labels for prepared drugs and other items in use on patients during surgical procedures. Codonics Safe Label System (SLS) is generally placed in, however not limited to, the peri-operative environment to identify syringes prepared for anesthesiology use during surgery. Additional uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS can also be used to print "non-surgical environment" color & text labels as required. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians

Source page: https://510kreport.com/device/K101439
Methodology: https://510kreport.com/methodology