Cleared Traditional

K771269 - BLOOD COLLECTION SET TYPE H

K771269 is an FDA 510(k) clearance for BLOOD COLLECTION SET TYPE H, manufactured by Berman, Pcp & Consultants, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K771269 · Berman, Pcp & Consultants, Inc. · General Hospital
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Sep 1977
Decision
84d
Days
Class 2
Risk

K771269 is an FDA 510(k) clearance for the BLOOD COLLECTION SET TYPE H. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Berman, Pcp & Consultants, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 Berman, Pcp & Consultants, Inc. devices

FDA 510(k) Submission Details - K771269

510(k) Number K771269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1977
Decision Date September 12, 1977
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPK Tubing, Fluid Delivery

All 31
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K771269.
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981
EXTENSION SET QUEST CODE #3000
K800825 · Quest Medical, Inc. · May 1980
CENTRAL CATHETER KIT
K780673 · Argon Medical Corp. · May 1978
MONITORING LINES & FLUID ADMIN.
K771387 · Norton Performance Plastics Corp. · Aug 1977
CONNECTORS
K770596 · Abco Dealers, Inc. · Jun 1977
TUBE HOLDING DEVICE
K770108 · Pharmaseal Div., Baxter Healthcare Corp. · Mar 1977