Cleared Traditional

K182927 - Pulmonary Cytology Brush (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182927 · Hobbs Medical, Inc. · Anesthesiology device
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Feb 2020
Decision
473d
Days
Class 2
Risk

K182927 is an FDA 510(k) clearance for the Pulmonary Cytology Brush. Classified as Brush, Biopsy, Bronchoscope (non-rigid) (product code BTG), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on February 7, 2020 after a review of 473 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Hobbs Medical, Inc. devices

Submission Details

510(k) Number K182927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2018
Decision Date February 07, 2020
Days to Decision 473 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
334d slower than avg
Panel avg: 139d · This submission: 473d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTG Brush, Biopsy, Bronchoscope (non-rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition 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 Anesthesiology devices follow this clearance model.