510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K062811Substantially Equivalent

Dpilog, Model Dpc-512

Life Outcomes, Inc., Highlands Ranch CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062811 is the FDA 510(k) clearance record for DPILOG, MODEL DPC-512, a class II device, cleared for Life Outcomes, Inc. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Life Outcomes, Inc. As of , FDA records show no recalls naming K062811.

Clearance record

Decision date
Received
(92 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Life Outcomes, Inc. 3957 Blue Pine Cir., Highlands Ranch CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260