Cleared Traditional

K843796 - STERILE WATER (FDA 510(k) Clearance)

K843796 · Paco Pharmaceutical Services, Inc. · Cardiovascular device
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Dec 1984
Decision
74d
Days
-
Risk

K843796 is an FDA 510(k) clearance for the STERILE WATER.

Submitted by Paco Pharmaceutical Services, Inc. (Princeton, US). The FDA issued a Cleared decision on December 10, 1984 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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 Paco Pharmaceutical Services, Inc. devices

Submission Details

510(k) Number K843796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date December 10, 1984
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -