510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090157Substantially Equivalent

Isolyser Home Sharps Management (Hsm), Model 800M; Isoly Sharps Management System (Sms), Models 2400M, 4000M, 10000M, 5.

WCM Waste & Compliance Management, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090157 is the FDA 510(k) clearance record for ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5., a class II device, cleared for Wcm Waste & Compliance Management, Inc. on under FDA product code MMK (Container, Sharps). FDA records list 2 510(k) clearances for Wcm Waste & Compliance Management, Inc., from to . As of , FDA records show no recalls naming K090157.

Clearance record

Decision date
Received
(102 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Wcm Waste & Compliance Management, Inc. 1330 Connecticut Ave., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260