# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Codonics.Incorporated
- Decided: Jul 11, 2025 after 72 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: 7 generations back to K904518 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
3 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101439: Codonics Safe Labeling System (SLS), Model 500I/500P, Codonics, Inc. (2011) Summary page 5.

## Indications for use
The Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features and safe and effective released SLS Software provides a simple computer-based bar code scanning/RFID & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes and (when configured and available) RFID parenteral vial information and formulary information, and to print labels embedded with RFID tags for prepared drugs and other items in use on patients during surgical procedures. Drug information is human readable on labels, 2D & Linear barcoded on labels, and RFID encoded as part of secondary container medication labels. Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features 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/K251352
Methodology: https://510kreport.com/methodology