# K964815: AP-4000, Air Pulse Sensory Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Sep 4, 1997 after 279 days
- Product code: LLN (Device, Vibration Threshold Measurement)
- Device class: 1
- Regulation: 21 CFR 882.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K823701 (1983). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921707: Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2, Pentax Precision Instrument Corp. (1992) Summary page 4.
- K870750: Keeler Pulsair Non Contact Tonometer, Keeler Instruments, Inc. (1987) Summary page 4.
- K942210: Puritan-Bennett 335 Respiratory Support System, Puritan Bennett Corp. (1996) Summary page 4.
- K823701: Motility Catheters, Mui Scientific (1983) Summary page 4.
- K904625: Synectics Liberty System, PC Polygraf and Polygram, Synectics-Dantec (1991) Summary page 4.
- (no number) Reflex Hammer, Manual: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K823700: Infusion Pump. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Most influential descendants
- K031790: Slide-on Endosheath System for Sensory Testing (2003), 0 descendants of its own

## Indications for use
The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso-Pharyngo-Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.

Source page: https://510kreport.com/device/K964815
Methodology: https://510kreport.com/methodology