Cleared Traditional

K871177 - NTH 101 UL

K871177 is an FDA 510(k) clearance for NTH 101 UL, manufactured by Aragona Medical, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K871177 · Aragona Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
199d
Days
Class 2
Risk

K871177 is an FDA 510(k) clearance for the NTH 101 UL. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Aragona Medical, Inc. (Woodcliff Lake, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 199 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 Aragona Medical, Inc. devices

FDA 510(k) Submission Details - K871177

510(k) Number K871177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1987
Decision Date October 09, 1987
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMT Device Classification - Class 2, Special Controls

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 65
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K871177.
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
K875270 · Air-Shields, Inc. · Jan 1988
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
K872742 · Air-Shields, Inc. · Oct 1987
BIRTHING ROOM WARMER
K871594 · Air-Shields, Inc. · Jun 1987
YSI MODEL 801
K865012 · Yellow Springs Instrument Co., Inc. · Mar 1987
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986