510(k) · Cleared
ClearedMiltex Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miltex, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Mar 4, 2005 as substantially equivalent to K021237 (CooperSurgical, Inc., 2003) after a 122-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- Mar 4, 2005
- Review
- 122 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932832 (1994). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
- 1 generation backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
- This deviceK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- Descendant · 4 generations on · 1 of its ownK142208 Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · 4 generations on · 0 of its ownK230621 LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · cites it directly8descendants
- K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · 2 generations on7descendants
- K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 3 generations on6descendants
- K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · 4 generations on1descendant
- K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932832 | Primus Insulated Forceps | Marlo Surgical Technology | 1994 | — |
| −1 | K021237 | Coopersurgical Laparoscopic Instruments | CooperSurgical, Inc. | 2003 | — |
| 0 (this device) | K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | 2005 | — |
| +1 | K052759 | Dan Monopolar Lap Accessories | Dannoritzer Medizintechnik GmbH & Co. KG | 2006 | 1 |
| +2 | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| +3 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| +4 | K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +4 | K230621 | LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 |
|---|---|---|---|
| * | K021237 | Coopersurgical Laparoscopic InstrumentsSummary page 1…aparoscopic Biopsy Punch and Forceps. Predicate Device [21 CER 807.92(a)(3)] CooperSurgical Laparoscopic Instruments- CooperSurgical Incorporated- K02 1237. The subj~ect devices have the same indications for use as the predicate devices, have stainless steel jaws, are bo… | 2003 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052759 (Dannoritzer Medizintechnik GmbH & Co. KG, 2006) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043013 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043013: Miltex Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043013
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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