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Moss Mark IV Nasal Tubes Cat.# 87168

by Mfg. and Research, Inc.

510(k) K872932

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872932 Date15 Sep 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Moss(R) Mark IV Nasal Tubes Cat.# 87168
510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Moss Mark IV Nasal Tubes Cat.# 87168 are Tubes, Gastrointestinal (and Accessories) designed for nasal insertion to facilitate decompression and enteral feeding. These tubes feature patented ‘Suction-Buster’ orifices to maintain uninterrupted function across the full suction range, ensuring efficient removal of air and liquids while minimizing occlusion.

Supplied as single-use devices, these tubes are intended for use in clinical settings such as gastroenterology and urology. They are classified under FDA regulation 876.5980 and received FDA 510(k) clearance (K872932) under a Traditional review pathway, determined as Substantially Equivalent (SESE). No additional sterility or MRI safety specifications are noted in the regulatory submission.

Other devices from Mfg. and Research, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties commonly use the Moss Mark IV Nasal Tubes, and why are they preferred in those fields?

    The Moss Mark IV Nasal Tubes are primarily used in gastroenterology and urology settings. They are designed for nasal insertion to manage decompression and enteral feeding, which are common procedures in these specialties. The patented ‘Suction-Buster’ orifices ensure reliable suction performance across a wide range of clinical scenarios, reducing the risk of occlusion and improving patient care during prolonged use.

  • Are these tubes meant for single-use or can they be reused? How does this affect their clinical application?

    The Moss Mark IV Nasal Tubes are supplied as single-use devices, meaning each tube is intended for one patient only. This design choice aligns with infection control best practices, reducing the risk of cross-contamination between patients. Single-use also simplifies inventory management and ensures consistent performance without degradation from repeated use.

  • What sizes or models are available for the Moss Mark IV Nasal Tubes, and how might a clinician choose the right one?

    While the provided data does not specify exact sizes or model variations, the Moss Mark IV Nasal Tubes are categorized under FDA product code KNT (KNT - Nasal Tubes). Clinicians typically select the appropriate size based on patient anatomy and clinical needs, such as tube diameter and length, though exact sizing details would require consulting the manufacturer’s product documentation or catalog.

  • How should these tubes be stored, and are there any special handling instructions to maintain their integrity?

    The Moss Mark IV Nasal Tubes are not explicitly noted for requiring specialized sterility or environmental storage conditions beyond standard single-use medical device handling. However, as with all sterile or single-use devices, they should be stored in a clean, dry place, protected from moisture, dust, and direct sunlight. The packaging should remain intact until use to preserve sterility and functionality.

  • What regulatory pathway was followed for FDA clearance, and does this affect how the device is used or prescribed?

    The Moss Mark IV Nasal Tubes received FDA 510(k) clearance (K872932) under a Traditional review pathway, determined as Substantially Equivalent (SESE) to a predicate device. This means the device was evaluated against an existing, legally marketed nasal tube and found to have equivalent safety and effectiveness. Clinically, this clearance confirms the device meets FDA standards for its intended use in decompression and enteral feeding, but it does not alter how the device is prescribed—only that it complies with regulatory requirements.