Cleared Traditional

K761172 - TRIS BUFFERED SALINE

K761172 is the FDA 510(k) clearance for TRIS BUFFERED SALINE by Bio/Data Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K761172 · Bio/Data Corp. · Hematology device
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Jan 1977
Decision
40d
Days
Class 2
Risk

K761172 is an FDA 510(k) clearance for the TRIS BUFFERED SALINE. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1977 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology 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 Bio/Data Corp. devices

Submission Details

510(k) Number K761172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1976
Decision Date January 10, 1977
Days to Decision 40 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 113d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K761172.
PLASMA, STANDARDIZED NORMAL
K790204 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979
TPC-LYOPHILIZED POOLED HUMAN PLASMA
K761091 · Bio/Data Corp. · Feb 1977
VERONAL BUFFER
K761171 · Bio/Data Corp. · Jan 1977
TRIS BUFFERED
K761173 · Bio/Data Corp. · Jan 1977
IMIDAZOLE BUFFER (0.05M)
K761175 · Bio/Data Corp. · Jan 1977
CALCIUM CHLORIDE (0.025M)
K761176 · Bio/Data Corp. · Jan 1977