510(k) · Cleared
ClearedManzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Langford IC Systems, Inc. · FEB Accessories, Cleaning, For Endoscope
Cleared on Oct 12, 2006 as substantially equivalent to K983017 (Custom Ultrasonics, 1998) and 2 other predicates after a 232-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Oct 12, 2006
- Review
- 232 days
- Class
- Class II
- Product code
- FEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K983017 (1998). 3 ancestors in all, the oldest K875280 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983017 Modification to System 83 PlusCustom Ultrasonics · 1998 · Recalled
- 1 generation backK043314 Manzi Cleaner SystemLangford IC Systems, Inc. · 2005
- This deviceK060458 Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent…Langford IC Systems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK101158 Lic Instrument Processing SystemLangford IC Systems, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K101158Lic Instrument Processing SystemLangford IC Systems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983017 | Modification to System 83 Plus | Custom Ultrasonics | 1998 | 2 |
| −1 | K043314 | Manzi Cleaner System | Langford IC Systems, Inc. | 2005 | — |
| 0 (this device) | K060458 | Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi… | Langford IC Systems, Inc. | 2006 | — |
| +1 | K101158 | Lic Instrument Processing System | Langford IC Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 FEB? 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 FEB device
- #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K983017 | Modification to System 83 PlusSummary page 1…ice Classification: 21 CFR § 876.1500, Proprietary Name: Manzi MSIO 2.0 PREDICATE DEVICE a) System 83 Plus T M Washer-Disinfector, K983017 Manzi Cleaner System, K0433 14 (Washer) b) Steris 20 Sterilant, K875280 3.0 INDICATIONS F… | 1998 |
| * | K043314 | Manzi Cleaner SystemSummary page 1…Proprietary Name: Manzi MSIO 2.0 PREDICATE DEVICE a) System 83 Plus T M Washer-Disinfector, K983017 Manzi Cleaner System, K0433 14 (Washer) b) Steris 20 Sterilant, K875280 3.0 INDICATIONS FOR USE The Manzi Mach I Instrument Clea… | 2005 |
| * | K875280 | Steris System 1 Processor and 20 SterilantSummary page 1…DEVICE a) System 83 Plus T M Washer-Disinfector, K983017 Manzi Cleaner System, K0433 14 (Washer) b) Steris 20 Sterilant, K875280 3.0 INDICATIONS FOR USE The Manzi Mach I Instrument Cleaner Processor System is indicated for use with the High… | 1988 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101158 | Lic Instrument Processing System | 2011 | 0 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K101158 (Langford IC Systems, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K983017.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FEB
111in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEB
15so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEB
356in 2025
MAUDE reports naming product code FEB, 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 | 2 | — | 0 | 39 |
| 2008 | 1 | — | 3 | 152 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 2 | — | 1 | 50 |
| 2011 | 3 | 111 | 0 | 32 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 27 |
| 2014 | 1 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 92 |
| 2016 | 2 | — | 2 | 103 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 2 | — | 0 | 62 |
| 2020 | 2 | — | 1 | 426 |
| 2021 | 0 | — | 1 | 575 |
| 2022 | 1 | — | 0 | 607 |
| 2023 | 1 | — | 1 | 998 |
| 2024 | 2 | — | 1 | 884 |
| 2025 | 0 | — | 3 | 356 |
| 2026 | 1 | — | 15 | — |
What is it indicated for?
The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060458: Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060458
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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