Cleared Traditional

K852761 - CILAS MODEL YM101

K852761 is an FDA 510(k) clearance for CILAS MODEL YM101, manufactured by Inframed, Inc.. The device is a Class 2 Anesthesiology device with product code LLO cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K852761 · Inframed, Inc. · Anesthesiology device
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Nov 1985
Decision
139d
Days
Class 2
Risk

K852761 is an FDA 510(k) clearance for the CILAS MODEL YM101. Classified as Laser, Neodymium:yag, Pulmonary Surgery (product code LLO), Class II - Special Controls.

Submitted by Inframed, Inc. (Brookline Village, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4500 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inframed, Inc. devices

FDA 510(k) Submission Details - K852761

510(k) Number K852761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1985
Decision Date November 14, 1985
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLO Device Classification - Class 2, Special Controls

Product Code LLO Laser, Neodymium:yag, Pulmonary Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - LLO Laser, Neodymium:yag, Pulmonary Surgery

All 10
Devices cleared under the same product code (LLO) and FDA review panel - the closest regulatory comparables to K852761.
LASER BRONCHOSCOPE SYSTEM
K861921 · Pilling Co. · Jun 1986
CO2 LASER BRONCHOSCOPE SYSTEM
K861583 · Richard Wolf Medical Instruments Corp. · May 1986
S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
K855095 · Surgical Laser Technologies, Inc. · Feb 1986
ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION
K852507 · Endo Lase, Inc. · Jul 1985
LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-
K850432 · Cooper Lasersonics, Inc. · Feb 1985