510(k) · Cleared
ClearedIsolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management System (SMS), Models 2400M, 4000M, 10000M, 5.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wcm Waste & Compliance Management, Inc. · MMK Container, Sharps
Cleared on May 4, 2009 as substantially equivalent to K943626 (Thantex Specialties, Inc., 1995) after a 102-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 4, 2009
- Review
- 102 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943626 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK943626 Isolyser Sharps Management System SMSThantex Specialties, Inc. · 1995
- This deviceK090157 Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps…Wcm Waste & Compliance Management, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943626 | Isolyser Sharps Management System SMS | Thantex Specialties, Inc. | 1995 | — |
| 0 (this device) | K090157 | Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management… | Wcm Waste & Compliance Management, Inc. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMK device
- #1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943626 | Isolyser Sharps Management System SMSSummary page 2…The Isolyser SMSm sharps containers are substantially equivalent in intended use, function and basic composition to the Isolyser SMS sharps containers approved in 510(k) K943626 and Sharps Compliance, Inc.'s Sharps Disposal by Mail System 15000 [5 10(k) unknown]. Specifically, the HSM 800m, SMS 2400m, SMS… | 1995 |
| * | — | Sharps Compliance, Inc.'s Sharps Disposal by Mail System 15000 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K943626.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMK
No recall names MMK since 2007.
Adverse event reports per year · MMK
5in 2025
MAUDE reports naming product code MMK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Isolyser Sharps Management Systems SMSm is a single-use, disposable, over-the-counter sharps container intended for use in clinical and non-clinical settings for the disposal of contaminated sharps and/or medical/red-bag wastes. The SMSm is marketed in five (5) different models: (1) Home Sharps Management (HSM) 800m, .98 liters, 3.45 x 2.72 x 7.29 (in.); (2) Sharps Management System (SMS) 2400m, 3.3 liters, 5 x 5x 10 (in.); (3) Sharps Management…
Read the full statement (234 words)
The Isolyser Sharps Management Systems SMSm is a single-use, disposable, over-the-counter sharps container intended for use in clinical and non-clinical settings for the disposal of contaminated sharps and/or medical/red-bag wastes. The SMSm is marketed in five (5) different models: (1) Home Sharps Management (HSM) 800m, .98 liters, 3.45 x 2.72 x 7.29 (in.); (2) Sharps Management System (SMS) 2400m, 3.3 liters, 5 x 5x 10 (in.); (3) Sharps Management System (SMS) 4000m, 5.97 liters, 8.47 x 5.99 x 8.87 (in.); (4) Sharps Management System (SMS) 10000m, 10.47 liters, 8.51 x 5.99 x 14.32 (in.); and (5) Sharps Management System (SMS) 5.3m, 21.1 liters, 11.93 x 9.87 x 14.68 (in.). *Each SMSm model is designed to safely and securely contain used medical sharps and/or medical/red-bag wastes prior to removal and subsequent disposal. The SMS 5.3m is intended only for the storage and disposal of filled approved sharps containers and/or medical/red-bag wastes. Once an empty SMSm container has been filled with used medical sharps and/or medical/red-bag wastes, the entire SMSm container is intended to be packaged and mailed-back to WCM Waste and Compliance Management, Inc. for proper disposal. The HSM 800m, SMS 2400m, SMS 4000m, SMS 10000m, and SMS 5.3m are intended for home use by home health care providers and for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMSm sharps containers are not intended for reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090157: Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management System (SMS), Models 2400M, 4000M, 10000M, 5..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090157
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026