Cleared Traditional

K073407 - PACIFICA

K073407 is an FDA 510(k) clearance for PACIFICA, manufactured by Or-Nim Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K073407 · Or-Nim Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
86d
Days
Class 2
Risk

K073407 is an FDA 510(k) clearance for the PACIFICA. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Or-Nim Medical , Ltd. (Washington, US). The FDA issued a Cleared decision on February 28, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - 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.

FDA 510(k) Submission Details - K073407

510(k) Number K073407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2007
Decision Date February 28, 2008
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - MUD Oximeter, Tissue Saturation

All 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K073407.
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
K082327 · Somanetics Corp. · Apr 2009
T-STAT 303 ISCHEMIA MONITORING SYSTEM
K081233 · Spectros Corporation · Jul 2008
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
K080769 · Somanetics Corp. · May 2008
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
K073656 · Hypermed, Inc. · Jan 2008
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
K061848 · Hypermed, Inc. · Nov 2006
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · Cas Medical Systems, Inc. · Sep 2006
K073407 · PACIFICA
Download PDF FDA Summary Or-Nim Medical , Ltd.