Cleared Traditional

K820927 - HBS POWDER

K820927 is the FDA 510(k) clearance for HBS POWDER by Dutchland Laboratories, Inc.. It is a Class 1 Microbiology device (product code KIP) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820927 · Dutchland Laboratories, Inc. · Microbiology device
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Apr 1982
Decision
20d
Days
Class 1
Risk

K820927 is an FDA 510(k) clearance for the HBS POWDER. Classified as Formulations, Balanced Salt Solutions (product code KIP), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2875 - the FDA microbiology 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 Dutchland Laboratories, Inc. devices

Submission Details

510(k) Number K820927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1982
Decision Date April 21, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIP Formulations, Balanced Salt Solutions
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2875
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KIP Formulations, Balanced Salt Solutions

All 15
Devices cleared under the same product code (KIP) and FDA review panel - the closest regulatory comparables to K820927.
SALINE 0.85% W/O PRESERVATIVE
K842724 · E K Ind., Inc. · Aug 1984
SALINE, 0.85%W/PRESERVATIVE
K842725 · E K Ind., Inc. · Aug 1984
DULBECCO'S PBS POWDER
K820923 · Dutchland Laboratories, Inc. · Apr 1982
EBS POWDER
K820928 · Dutchland Laboratories, Inc. · Apr 1982
EARLE'S BALANCED SALTS SOULTION
K810779 · Dutchland Laboratories, Inc. · May 1981
HANKS' BALANCED SALT SOLUTION W/O CA-MG
K810766 · Dutchland Laboratories, Inc. · May 1981