510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K931988Substantially Equivalent

3P (Pulmonary Percussive Pack)

Delta Medical Manuf, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931988 is the FDA 510(k) clearance record for 3P (PULMONARY PERCUSSIVE PACK), a class II device, cleared for Delta Medical Manuf, Inc. on under FDA product code BYI (Percussor, Powered-Electric). FDA records list one 510(k) clearance for Delta Medical Manuf, Inc. As of , FDA records show no recalls naming K931988.

Clearance record

Decision date
Received
(554 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Delta Medical Manuf, Inc. P.O. Box 52038, Raleigh NC
510(k) summary
Summary
Third party review
No

Clearances, product code BYI

Trailing 12 months
1 clearance under product code BYI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BYI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260