510(k) · Cleared
ClearedMacroduct Advanced Model 3710
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup, Inc. · KTB Device, Iontophoresis, Specific Uses
Cleared on Jul 27, 2018 as substantially equivalent to K853973 (Wescor, Inc., 1985) after a 140-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jul 27, 2018
- Review
- 140 days
- Class
- Class II
- Product code
- KTB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853973 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK853973 Wescor Model 3700 Webster Sweat InducerWescor, Inc. · 1985
- This deviceK180627 Macroduct Advanced Model 3710Elitechgroup, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853973 | Wescor Model 3700 Webster Sweat Inducer | Wescor, Inc. | 1985 | — |
| 0 (this device) | K180627 | Macroduct Advanced Model 3710 | Elitechgroup, Inc. | 2018 | — |
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 KTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K853973 | Wescor Model 3700 Webster Sweat InducerSummary page 4…510(k) Product code(s) Number Macroduct® Model 3700-SYS K853973 KTB Section 6 – 510(k) Summary Page 6.1 of 6.5 === Page 5… | 1985 |
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.
How does its category compare?
All KTB devicesKTB Device, Iontophoresis, Specific Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KTB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KTB
Too few KTB 510(k)s in any year since 2007 to give a median.
Recalls per year · KTB
No recall names KTB since 2007.
Adverse event reports per year · KTB
1in 2012
MAUDE reports naming product code KTB, 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 | 4 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180627: Macroduct Advanced Model 3710.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180627
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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