510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964815Substantially Equivalent

Ap-4000, Air Pulse Sensory Stimulator

Pentax Precision Instrument Corp., Miramar FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964815 is the FDA 510(k) clearance record for AP-4000, AIR PULSE SENSORY STIMULATOR, a class I device, cleared for Pentax Precision Instrument Corp. on under FDA product code LLN (Device, Vibration Threshold Measurement). FDA records list 67 510(k) clearances for Pentax Precision Instrument Corp., from to . As of , FDA records show no recalls naming K964815.

Clearance record

Decision date
Received
(279 days to decision)
Product code
LLN Device, Vibration Threshold Measurement
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Applicant
Pentax Precision Instrument Corp. 3117 Commerce Pkwy., Miramar FL
510(k) summary
Summary
Third party review
No

Clearances, product code LLN

Trailing 12 months

FDA records hold no clearances under product code LLN in the trailing twelve months.

FDA records show no clearances under product code LLN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260