Codonics Safe Labeling System (SLS), Model 500I/500P
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101439 FDA 510(k)
- FDA Product Code
- BSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5160 FDA 510(k)
- Regulation Number
- 868.5160 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Codonics Safe Labeling System (SLS), Model 500I/500P, is a barcode-based labeling solution designed for anesthesia workflows. It integrates with gas-machine anesthesia systems to enhance drug identification, labeling, and safety by automating label generation and verification using electronic barcode scanning.
This system is intended for single-use in clinical settings, such as operating rooms, and relies on barcode technology to confirm drug identity via FDA NDC or other drug identification barcodes. Supplied as a modular system, it requires no special sterility handling but must be maintained per manufacturer instructions. Authorized under FDA 510(k) clearance and MDR compliance, it is classified as a Class II medical device under regulation 868.5160.
Frequently asked questions
What clinical workflows is the Codonics Safe Labeling System (SLS) designed to support, and how does it improve safety?
The Codonics SLS, Model 500I/500P, is specifically designed to integrate with anesthesia gas-machine systems in operating rooms and similar clinical settings. It enhances safety by automating the generation and verification of drug labels using barcode technology, ensuring accurate identification of medications via FDA NDC or other drug barcodes. This reduces the risk of mislabeling or misidentification, which is critical in high-stakes anesthesia workflows where errors can have serious consequences.
Is the Codonics SLS intended for single-use or reusable applications, and what maintenance requirements apply?
The Codonics SLS is explicitly designed for single-use in clinical settings, such as operating rooms. While it does not require special sterility handling (e.g., terminal sterilization), it must be maintained according to the manufacturer’s instructions to ensure proper functionality. This includes routine upkeep to sustain its barcode scanning and label generation capabilities over repeated use cycles in a clinical environment.
What types of barcodes does the Codonics SLS recognize for drug identification, and how does this impact workflow integration?
The Codonics SLS is configured to verify drug identity using FDA NDC barcodes or other standardized drug identification barcodes. This compatibility ensures seamless integration with existing anesthesia workflows, as it directly reads labels already present on pharmaceutical packaging. Clinicians can rely on the system’s automated verification to confirm medication identity before administration, minimizing manual errors.
Are there specific storage requirements for the Codonics SLS, and how should it be handled between uses?
The Codonics SLS does not require specialized sterility storage like surgical instruments, as it is not sterile by design. However, it should be stored in a clean, dry environment per the manufacturer’s guidelines to prevent dust, moisture, or physical damage. Since it is modular and intended for single-use in clinical settings, it should be handled according to standard operating procedures for medical devices—avoiding contamination and ensuring accessibility for authorized personnel during anesthesia procedures.
What regulatory pathways does the Codonics SLS follow, and how does this affect its use in clinical practice?
The Codonics SLS, Model 500I/500P, is authorized under FDA 510(k) clearance and MDR compliance, classifying it as a Class II medical device under regulation 868.5160. This means it has undergone rigorous review by the FDA to demonstrate substantial equivalence to predicate devices, ensuring its safety and effectiveness for its intended use in anesthesia workflows. Clinicians can rely on this regulatory clearance as evidence of the system’s compliance with U.S. standards for medical devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Safe Label System (SLS) - Codonics | Innovator of the Safe Label System®, Home - Codonics | Innovator of the Safe Label System®, PDF SLS User Manual - codonics.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101439 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Codonics Inc.
- FDA Applicant
- Codonics, Inc.
Sources (2)
- FDA 510(k) K101439 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026