510(k) Report

510(k) · Cleared

Cleared

Isolyser Sharps Management System SMS

K943626510(k) TraditionalCleared Jun 16, 1995325-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Thantex Specialties, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jun 16, 1995 after a 325-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 16, 1995
Review
325 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943626 Isolyser Sharps Management System SMSThantex Specialties, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK090156 Isolyser Sharps Room System, Model 800; Isolyser Sharps Management…Wcm Waste & Compliance Management, Inc. · 2009
  3. Descendant · cites it directly · 0 of its ownK090157 Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps…Wcm Waste & Compliance Management, Inc. · 2009
  4. Descendant · cites it directly · 0 of its ownK970547 Isolyser SDS Sharps ContainerThantex Specialties, Inc. · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K090156Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System, Models 2400…Wcm Waste & Compliance Management, Inc. · 2009 · cites it directly0descendants
  • K090157Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management System (SMS)…Wcm Waste & Compliance Management, Inc. · 2009 · cites it directly0descendants
  • K970547Isolyser SDS Sharps ContainerThantex Specialties, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943626Isolyser Sharps Management System SMSThantex Specialties, Inc.1995—
+1K090156Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System…Wcm Waste & Compliance Management, Inc.2009—
+1K090157Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management…Wcm Waste & Compliance Management, Inc.2009—
+1K970547Isolyser SDS Sharps ContainerThantex Specialties, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200920
FIG. 1 — Lineage of K943626, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090156Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System, Models 2400…Wcm Waste & Compliance Management, Inc.20090
K090157Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management System (SMS)…Wcm Waste & Compliance Management, Inc.20090
K970547Isolyser SDS Sharps ContainerThantex Specialties, Inc.19970

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?

  • Of its descendants, K090156 (Wcm Waste & Compliance Management, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

More from Thantex Specialties, Inc.

21 FDA decisions under this applicant name. See the company

  • K970547Isolyser SDS Sharps ContainerThantex Specialties, Inc. · 1997
  • K961083Orex Surgeon's VestThantex Specialties, Inc. · 1996
  • K942200Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsThantex Specialties, Inc. · 1995
  • K945755Orex (R) O.R Equipment DrapesThantex Specialties, Inc. · 1995
  • K945223Orex Isolation GownThantex Specialties, Inc. · 1995

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https://510kreport.com/device/K943626 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943626: Isolyser Sharps Management System SMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943626

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026