Cleared Traditional

K120884 - PERICAM PSI

K120884 is an FDA 510(k) clearance for PERICAM PSI, manufactured by Perimed AB. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K120884 · Perimed AB · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
102d
Days
Class 2
Risk

K120884 is an FDA 510(k) clearance for the PERICAM PSI. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Perimed AB (Jarfalla, SE). The FDA issued a Cleared decision on July 3, 2012 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K120884

510(k) Number K120884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2012
Decision Date July 03, 2012
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 39
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K120884.
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
K123216 · Aimago SA · Feb 2013
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943 · Moor Instruments, Ltd. · Jan 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA
K121429 · Aimago SA · Aug 2012
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
K073593 · Deltex Medical Limited · Jan 2009
MOORLD12-B1 LASER DOPPLER BURNS IMAGER
K060976 · Moor Instruments, Ltd. · Mar 2007
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
K063586 · Moor Instruments, Ltd. · Jan 2007