510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081138Unknown

Safeflo Vena Cava Filter

Rmt Medical Technilogies, Inc., Philadelphia PA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081138 is the FDA 510(k) clearance record for SAFEFLO VENA CAVA FILTER, a class II device, cleared for Rmt Medical Technilogies, Inc. on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list one 510(k) clearance for Rmt Medical Technilogies, Inc. As of , FDA records show no recalls naming K081138.

Clearance record

Decision date
Received
(381 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Rmt Medical Technilogies, Inc. 1835 Market St., Philadelphia PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTK

Trailing 12 months

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

FDA records show no clearances under product code DTK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTK, 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