510(k) · Cleared
ClearedIsolyser Sharps Room System, Model 800; Isolyser Sharps Management System, Models 2400, 4000, 10000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wcm Waste & Compliance Management, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 1, 2009 as substantially equivalent to K943626 (Thantex Specialties, Inc., 1995) after a 222-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 1, 2009
- Review
- 222 days
- Class
- Class II
- Product code
- FMI
- 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 deviceK090156 Isolyser Sharps Room System, Model 800; Isolyser Sharps Management…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) | K090156 | Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System… | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 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? (1)
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…es The Isolyser SMS sharps containers are substantially equivalent in intended use, function, and basic composition to the sharps containers approved under 510(k) number K943626. The Isolyser SMS sharps containers have similar technological characteristics to the sharps containers approved in 510(k) K943 6… | 1995 |
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 FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The Isolyser Sharps Management System (SMS) is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS sharps containers are designed to safely and securely contain used medical sharps prior to removal and subsequent disposal. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800, .98 liters; (2) Sharps Management System (SMS) 2400, 3.3 liters; (3)…
Read the full statement (188 words)
The Isolyser Sharps Management System (SMS) is a disposable over-the-counter sharps container that is intended for the safe and effective disposal of used medical sharps. The SMS sharps containers are designed to safely and securely contain used medical sharps prior to removal and subsequent disposal. The SMS is marketed in four (4) different models: (1) Sharps Room System (SRS) 800, .98 liters; (2) Sharps Management System (SMS) 2400, 3.3 liters; (3) Sharps Management System (SMS) 4000, 5.97 liters; and (4) Sharps Management System (SMS) 10000, 10.47 liters. Each SMS model includes a water-based acrylamide solution that, when mixed with the provided catalysts, creates a polymer that encapsulates used medical sharps. Once the polymer has formed, the entire SMS container, including its contents, may be disposed in a user's ordinary trash in most states. It is the user's responsibility to dispose of the SMS container in accordance with Federal, State and Local regulations. The SRS 800, SMS 2400, SMS 4000, SMS 10000 are intended for use by small quantity health care providers such as dentists, medical doctors, veterinarians, and laboratories. The SMS sharps containers are not intended for reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090156: Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System, Models 2400, 4000, 10000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090156
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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