Cleared Traditional

K141087 - INTER-THERM PEDIATRIC HMEF

K141087 is an FDA 510(k) clearance for INTER-THERM PEDIATRIC HMEF, manufactured by Intersurgical Incorporated. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K141087 · Intersurgical Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
290d
Days
Class 2
Risk

K141087 is an FDA 510(k) clearance for the INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Intersurgical Incorporated (Liverpool, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 290 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Intersurgical Incorporated devices

FDA 510(k) Submission Details - K141087

510(k) Number K141087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2014
Decision Date February 12, 2015
Days to Decision 290 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 129d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 - CAH Filter, Bacterial, Breathing-circuit

All 91
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K141087.
Altera Filter and HME/Filter
K192713 · Meditera Tibbi Malzeme San VE Tic AS · Mar 2020
Servo Guard
K182862 · Maquet Critical Care AB · Oct 2019
SafeBreath Filter Mouthpiece
K190022 · MD Diagnostics Limited · Sep 2019
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005