Cleared Traditional

K883908 - 3D VASCULAR RECORDER

K883908 is an FDA 510(k) clearance for 3D VASCULAR RECORDER, manufactured by D. E. Hokanson, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K883908 · D. E. Hokanson, Inc. · Cardiovascular device
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Oct 1988
Decision
43d
Days
Class 2
Risk

K883908 is an FDA 510(k) clearance for the 3D VASCULAR RECORDER. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Issaquah, US). The FDA issued a Cleared decision on October 28, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - the FDA cardiovascular device oversight 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 D. E. Hokanson, Inc. devices

FDA 510(k) Submission Details - K883908

510(k) Number K883908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date October 28, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 32
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K883908.
EC6 PLETHYSMOGRAPH
K982707 · D. E. Hokanson, Inc. · Aug 1998
VASOCOR PVR 100
K973659 · Vasocor, Inc. · Dec 1997
DOPCORD PPG
K884451 · Huntleigh Technology, Inc. · Jan 1989
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
K872517 · D. E. Hokanson, Inc. · Oct 1987
PULSE CUFF RECORDER MODEL PCR100
K863702 · Imex Medical Systems, Inc. · Jun 1987
VASOPULSE(TM)/MODEL 5000
K863803 · Sonicaid, Inc. · May 1987