Cleared Traditional

K761327 - IV SETS 2000 SERIES (HS-200,2L0,220)

K761327 is an FDA 510(k) clearance for IV SETS 2000 SERIES (HS-200, manufactured by Extracorporeal Medical Specialities, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K761327 · Extracorporeal Medical Specialities, Inc. · General Hospital
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Jan 1977
Decision
35d
Days
Class 2
Risk

K761327 is an FDA 510(k) clearance for the IV SETS 2000 SERIES (HS-200,2L0,220). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1977 after a review of 35 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 Extracorporeal Medical Specialities, Inc. devices

FDA 510(k) Submission Details - K761327

510(k) Number K761327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1976
Decision Date January 31, 1977
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K761327.
PIGGYBACK VENOSET W/0.22 FILTER
K770518 · Abbott Laboratories · Apr 1977
ERIKA I.V. ADMINISTRATION SET
K770171 · Erika, Inc. · Mar 1977
VENOSET FOR I.V. FAT EMULSION
K770051 · Abbott Laboratories · Feb 1977
CAP, INJECTION (#4600)
K760103 · Jelco Laboratories · Jul 1976
FILTER, I.V. (#4700)
K760110 · Jelco Laboratories · Jul 1976
FILTER, I.V., WITH FLASH BULB (#4701)
K760111 · Jelco Laboratories · Jul 1976