510(k) Report

510(k) · Cleared

Cleared

AP-4000, Air Pulse Sensory Stimulator

K964815510(k) TraditionalCleared Sep 4, 1997279-day reviewClass I21 CFR 882.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pentax Precision Instrument Corp. · LLN Device, Vibration Threshold Measurement

Cleared on Sep 4, 1997 as substantially equivalent to K921707 (Pentax Precision Instrument Corp., 1992) and 4 other predicates after a 279-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it.

Decided
Sep 4, 1997
Review
279 days
Class
Class I
Product code
LLN
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K823701 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestor2003: 1 descendant clearedK823701 · Motility Catheters · Mui Scientific · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K823701 · Motility Catheters · Mui Scientific · 19830
  1. Root · 1 generation backK823701 Motility CathetersMui Scientific · 1983
  2. This deviceK964815 AP-4000, Air Pulse Sensory StimulatorPentax Precision Instrument Corp. · 1997
  3. Descendant · cites it directly · 0 of its ownK031790 Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K823701Motility CathetersMui Scientific1983—
0 (this device)K964815AP-4000, Air Pulse Sensory StimulatorPentax Precision Instrument Corp.1997—
+1K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199210
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K964815, 1983–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K921707Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2
Summary page 4
…ory Stimulator : Classification Name: Endoscope and Accessories (78KOG) {876.1500} PREDICATED DEVICE(S) INFORMATION: FNL-15P2, Fiber NasoPharyngo(Laryngo)scope Pentax K921707 Reflex Hammer, Manual *Class 1 device, no 510(k) clearance Keeler Non Contact Tonometer Keeler Instruments K870750 Companion 335,…
Pentax Precision Instrument Corp.19921
*K870750Keeler Pulsair Non Contact Tonometer
Summary page 4
…N: FNL-15P2, Fiber NasoPharyngo(Laryngo)scope Pentax K921707 Reflex Hammer, Manual *Class 1 device, no 510(k) clearance Keeler Non Contact Tonometer Keeler Instruments K870750 Companion 335, Nasal CPAP System Nellcor Puritan Bennett K942210 Motility Catheter MAI K823701 Infusion Pump MAI K823700 Synetics…
Keeler Instruments, Inc.1987—
*K942210Puritan-Bennett 335 Respiratory Support System
Summary page 4
…flex Hammer, Manual *Class 1 device, no 510(k) clearance Keeler Non Contact Tonometer Keeler Instruments K870750 Companion 335, Nasal CPAP System Nellcor Puritan Bennett K942210 Motility Catheter MAI K823701 Infusion Pump MAI K823700 Synetics liberty System, PC Polygraph . Synetics - . K904625 DEVICE DESCR…
Puritan Bennett Corp.1996—
*K823701Motility Catheters
Summary page 4
…evice, no 510(k) clearance Keeler Non Contact Tonometer Keeler Instruments K870750 Companion 335, Nasal CPAP System Nellcor Puritan Bennett K942210 Motility Catheter MAI K823701 Infusion Pump MAI K823700 Synetics liberty System, PC Polygraph . Synetics - . K904625 DEVICE DESCRIPTION: The AP-4000, Air Puls…
Mui Scientific1983—
Kept off the family treeK823700Infusion 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
…Keeler Non Contact Tonometer Keeler Instruments K870750 Companion 335, Nasal CPAP System Nellcor Puritan Bennett K942210 Motility Catheter MAI K823701 Infusion Pump MAI K823700 Synetics liberty System, PC Polygraph . Synetics - . K904625 DEVICE DESCRIPTION: The AP-4000, Air Pulse Sensory Stimulator, is a…
*K904625Synectics Liberty System, PC Polygraf and Polygram
Summary page 4
…anion 335, Nasal CPAP System Nellcor Puritan Bennett K942210 Motility Catheter MAI K823701 Infusion Pump MAI K823700 Synetics liberty System, PC Polygraph . Synetics - . K904625 DEVICE DESCRIPTION: The AP-4000, Air Pulse Sensory Stimulator, is an endoscoplc accessory that must be used with the Pentax FNL-…
Synectics-Dantec1991—
*—Reflex Hammer, Manual
Named without a submission number
—

Also cleared against K921707: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.20030

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K031790 (Vision-Sciences, Inc., 2003) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K921707.

How does its category compare?

All LLN devices

LLN Device, Vibration Threshold Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLN

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLN

Too few LLN 510(k)s in any year since 2007 to give a median.

Recalls per year · LLN

No recall names LLN since 2007.

Adverse event reports per year · LLN

No MAUDE report names LLN since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K921707

3 other devices cite the same predicate.

  • K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd. · 2001
  • K011869Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentThe Olympus Optical Co. · 2001
  • K992526Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999

More from Pentax Precision Instrument Corp.

67 FDA decisions under this applicant name. See the company

  • K041395EG-3630URPentax Precision Instrument Corp. · 2004
  • K041397EG-3830UTPentax Precision Instrument Corp. · 20041 recall
  • K041396FG-36UX Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 20041 recall
  • K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
  • K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003

Recent decisions in LLN

The LLN category page

  • K072882Pain Vision, Model PS-2100Osachi Co., Ltd. · 2009
  • K030829VPT MeterXilas Medical, Inc. · 2003
  • K010981Gsa Genito Sensory AnalyzerMedoc Ltd. Advanced Medical Systems · 2001
  • K964622Medi-DX 7000Neuro-Diagnostic Assoc. · 1997
  • K970180Vsa 3000 Vibratoryn Sensory AnalyzerEare Consulting Service · 1997

https://510kreport.com/device/K964815 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964815: AP-4000, Air Pulse Sensory Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964815

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026