Cleared Traditional

K821995 - SOLUTION ADMINISTRATION SET (W/O NEEDLE)

K821995 is an FDA 510(k) clearance for SOLUTION ADMINISTRATION SET (W/O NEEDLE), manufactured by Bertex Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K821995 · Bertex Laboratories, Inc. · General Hospital
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Aug 1982
Decision
29d
Days
Class 2
Risk

K821995 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SET (W/O NEEDLE). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Bertex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 Bertex Laboratories, Inc. devices

FDA 510(k) Submission Details - K821995

510(k) Number K821995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1982
Decision Date August 05, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 859
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