Cleared Traditional

K251352 - Codonics Safe Labeling System-Point of ...

Also marketed or referenced as:
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

K251352 is an FDA 510(k) clearance for Codonics Safe Labeling System-Point of ..., manufactured by Codonics.Incorporated. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K251352 · Codonics.Incorporated · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
72d
Days
Class 2
Risk

K251352 is an FDA 510(k) clearance for the Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and relat.... Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Codonics.Incorporated (Middleburg Heights, US). The FDA issued a Cleared decision on July 11, 2025 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Codonics.Incorporated devices

FDA 510(k) Submission Details - K251352

510(k) Number K251352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2025
Decision Date July 11, 2025
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 140d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSZ Gas-machine, Anesthesia

All 110
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