Cleared Traditional

K811218 - ACMI ASPIRATOR KIT #8808

K811218 is the FDA 510(k) clearance for ACMI ASPIRATOR KIT #8808 by American Cystocope Makers, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K811218 · American Cystocope Makers, Inc. · Ear, Nose, Throat device
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Jul 1981
Decision
58d
Days
Class 2
Risk

K811218 is an FDA 510(k) clearance for the ACMI ASPIRATOR KIT #8808. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by American Cystocope Makers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Cystocope Makers, Inc. devices

Submission Details

510(k) Number K811218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date July 01, 1981
Days to Decision 58 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 89d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 160
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K811218.
VARIOUS TYPES OF LIGHT SOURCE HANDLES
K822257 · Kelleher Corp. · Oct 1982
PENTAX BRONCHOFIBERSCOPE #FB-19E
K822844 · Pentax Precision Instrument Corp. · Oct 1982
RIGID FIBEROPTIC ENDOSCOPES
K822180 · Kelleher Corp. · Aug 1982
PENTAX BRONCHOFIBERSCOPE #FB-15A
K811059 · Pentax Precision Instrument Corp. · May 1981
PENTAX BROCHOFIBERSCOPE MODEL FB-17D,
K792342 · Pentax Precision Instrument Corp. · Dec 1979
PENTEX BRONCHOFIBERSCOPE MODEL FB-17A
K792267 · Pentax Precision Instrument Corp. · Dec 1979