Cleared Traditional

K936171 - TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY

K936171 is an FDA 510(k) clearance for TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY, manufactured by Advanced Clinical Diagnostics. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K936171 · Advanced Clinical Diagnostics · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
42d
Days
Class 1
Risk

K936171 is an FDA 510(k) clearance for the TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Advanced Clinical Diagnostics (Toledo, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - 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 Advanced Clinical Diagnostics devices

FDA 510(k) Submission Details - K936171

510(k) Number K936171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date February 03, 1994
Days to Decision 42 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 77d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

KIR Device Classification - Class 1, General Controls

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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 - KIR Cells, Animal And Human, Cultured

All 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K936171.
MRC-5 CULTURE CELL
K933925 · Neogenex · Mar 1994
LLCMK2 CULTURE CELLS
K933926 · Neogenex · Mar 1994
RHESUS MONKEY KIDNEY CELLS
K936169 · Advanced Clinical Diagnostics · Feb 1994
RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
K936172 · Advanced Clinical Diagnostics · Feb 1994
RABBIT KIDNEY CELLS - R.K.C.
K934934 · Advanced Clinical Diagnostics · Jan 1994
HELA-229/HELA CELLS
K934973 · Advanced Clinical Diagnostics · Jan 1994