# K082528: Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Noble Anesthesia-Air, Inc.
- Decided: Mar 6, 2009 after 185 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K771653 (1977). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034046: RNK Telephonic Stethoscope, Model TR-1, Rnk Products (2004). Our reading of the summary gave K030446, FDA’s number for Repicci Locked Keel Tibial Bearing (Biomet, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “RNK Products Stethoscope”.
- K072026: RNK Electronic Stethoscope, Rnk Products, Inc. (2007) Summary page 1.
- K062481: Sereno Electronic Stethoscope, Pishon High Tech Co., Ltd. (2006) Summary page 1.
- K991367: Meditron Stethoscope System, Meditron AS (1999) Summary page 1.

## Indications for use
The Noble Anesthesia-Air Snor-Scope PlusTM Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope. In addition, the Noble Anesthesia-Air Snor-Scope Plus Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia by an anesthesia care professional. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.

Source page: https://510kreport.com/device/K082528
Methodology: https://510kreport.com/methodology
