510(k) · Cleared
ClearedLic Instrument Processing System
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 May 6, 2011 as substantially equivalent to K060458 (Langford IC Systems, Inc., 2006) after a 375-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- May 6, 2011
- Review
- 375 days
- Class
- Class II
- Product code
- FEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983017 (1998). 4 ancestors in all, the oldest K875280 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK983017 Modification to System 83 PlusCustom Ultrasonics · 1998 · Recalled
- 2 generations backK043314 Manzi Cleaner SystemLangford IC Systems, Inc. · 2005
- 1 generation backK060458 Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent…Langford IC Systems, Inc. · 2006
- This deviceK101158 Lic Instrument Processing SystemLangford IC Systems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983017 | Modification to System 83 Plus | Custom Ultrasonics | 1998 | 2 |
| −2 | K043314 | Manzi Cleaner System | Langford IC Systems, Inc. | 2005 | — |
| −1 | K060458 | Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi… | Langford IC Systems, Inc. | 2006 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K060458 | Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant…Summary page 1…EVICE The LIC Instrument Processing System (KI0l 158) claims equivalence to the Manzi Mach I Instrument Cleaner - Processor System (K060458) found substantially equivalent on 10/12/2006. The predicate device is cleared for use with the MSIO Sterilant… | 2006 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water. The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level…
Read the full statement (202 words)
The LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water.
The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.
The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101158: Lic Instrument Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101158
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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