Cleared Traditional

K810005 - SAFEED EXTENSION TUBES

K810005 is an FDA 510(k) clearance for SAFEED EXTENSION TUBES, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K810005 · Terumo Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
30d
Days
Class 2
Risk

K810005 is an FDA 510(k) clearance for the SAFEED EXTENSION TUBES. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on February 5, 1981 after a review of 30 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K810005

510(k) Number K810005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1981
Decision Date February 05, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 23
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K810005.
CHURCHILL EXTENSION TUBE
K861626 · Churchill Corp. · Jun 1986
CHURCHILL-H EXTENSION TUBE
K854629 · Churchill Corp. · Dec 1985
C-FLEX MEDICAL GRADE TUBING
K833076 · Concept, Inc. · Nov 1983
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