Cleared Traditional

K834579 - BIOSPAL 2400S

K834579 is an FDA 510(k) clearance for BIOSPAL 2400S, manufactured by Hospal Medical Corp.. The device is a Class 1 Pathology device with product code KDT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K834579 · Hospal Medical Corp. · Pathology device
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Feb 1984
Decision
37d
Days
Class 1
Risk

K834579 is an FDA 510(k) clearance for the BIOSPAL 2400S. Classified as Container, Specimen Mailer And Storage, Sterile (product code KDT), Class I - General Controls.

Submitted by Hospal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3250 - the FDA pathology 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 Hospal Medical Corp. devices

FDA 510(k) Submission Details - K834579

510(k) Number K834579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date February 04, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 77d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

KDT Device Classification - Class 1, General Controls

Product Code KDT Container, Specimen Mailer And Storage, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3250
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 - KDT Container, Specimen Mailer And Storage, Sterile

All 7
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