Cleared Traditional

K061071 - V-808 ATOM TRANSCAPSULE

K061071 is an FDA 510(k) clearance for V-808 ATOM TRANSCAPSULE, manufactured by Atom Medical, Inc.. The device is a Class 2 General Hospital device with product code FPL cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K061071 · Atom Medical, Inc. · General Hospital
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Aug 2006
Decision
134d
Days
Class 2
Risk

K061071 is an FDA 510(k) clearance for the V-808 ATOM TRANSCAPSULE. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by Atom Medical, Inc. (Ivyland, US). The FDA issued a Cleared decision on August 29, 2006 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5410 - 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 Atom Medical, Inc. devices

FDA 510(k) Submission Details - K061071

510(k) Number K061071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date August 29, 2006
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPL Device Classification - Class 2, Special Controls

Product Code FPL Incubator, Neonatal Transport
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5410
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 - FPL Incubator, Neonatal Transport

All 11
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K061071.
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
K103525 · International Biomedical, Ltd. · May 2011
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103524 · International Biomedical, Ltd. · Apr 2011
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103527 · International Biomedical, Ltd. · Apr 2011
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · Air-Shields, Inc. · Jun 1994
TI-1000 TRANSPORT INCUBATOR
K831028 · Narco Scientific · May 1983
REVISED BATTERY CHARGER
K790689 · Vickers America Medical Corp. · May 1979