Cleared Traditional

ATMOS Scope (507.7000.0) (K232015) - FDA 510(k) Clearance

Also marketed or referenced as:
ATMOS Scope Pro (507.7050.0) ATMOS Scope iPrime (507.7060.0)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232015 · Atmos Medizintechnik GmbH & Co. KG · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
28d
Days
Class 2
Risk

K232015 is an FDA 510(k) clearance for the ATMOS Scope (507.7000.0). Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Atmos Medizintechnik GmbH & Co. KG (Lenzkirch, DE). The FDA issued a Cleared decision on August 3, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 Atmos Medizintechnik GmbH & Co. KG devices

Submission Details

510(k) Number K232015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2023
Decision Date August 03, 2023
Days to Decision 28 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 66
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K232015.
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K243380 · Olympus Medical Systems Corporation · Mar 2025
MonoStereo
K234096 · Medicaltek Co., Ltd. · Sep 2024
Rhinolaryngoscope system
K232435 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Apr 2024
PatCom Distal Chip Endoscope
K222587 · H&A Mui Enterprises, Inc. · Jul 2023
Single-use Flexible Rhinolaryngoscope
K230536 · Hunan Vathin Medical Instrument Co., Ltd. · Jun 2023
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · Olympus Medical Systems Corp. · Dec 2022