Cleared Traditional

K234015 - Caphosol® Artifical Saliva (32 doses sachet box) (FDA 510(k) Clearance)

K234015 · Eusa Pharma (Uk) Limited · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
83d
Days
-
Risk

K234015 is an FDA 510(k) clearance for the Caphosol® Artifical Saliva (32 doses sachet box). Classified as Saliva, Artificial (product code LFD).

Submitted by Eusa Pharma (Uk) Limited (Hemel Hempstead, GB). The FDA issued a Cleared decision on March 11, 2024 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Eusa Pharma (Uk) Limited devices

Submission Details

510(k) Number K234015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2023
Decision Date March 11, 2024
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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