Cleared Traditional

K880109 - CYSTINE TRYPTIC MEDIUM BASE

K880109 is the FDA 510(k) clearance for CYSTINE TRYPTIC MEDIUM BASE by Hardy Media. It is a Class 1 Microbiology device (product code KZI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K880109 · Hardy Media · Microbiology device
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Mar 1988
Decision
84d
Days
Class 1
Risk

K880109 is an FDA 510(k) clearance for the CYSTINE TRYPTIC MEDIUM BASE. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 30, 1988 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2330 - 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 Hardy Media devices

Submission Details

510(k) Number K880109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date March 30, 1988
Days to Decision 84 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
18d faster than avg
Panel avg: 102d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 29
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K880109.
MIDDLEBROOK 7H9 BROTH
K880122 · Hardy Media · Mar 1988
LOWENSTEIN-JENSEN, GRUFT
K880131 · Hardy Media · Mar 1988
MIDDLEBROOK 7H11 AGAR
K880134 · Hardy Media · Mar 1988
WALLENSTEIN MEDIUM SLANT
K880138 · Hardy Media · Mar 1988
POTATO DEXTROSE AGAR
K880127 · Hardy Media · Mar 1988
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748
K873952 · Lakewood Biochemical Co., Inc. · Oct 1987