510(k) · Cleared
ClearedInstalief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Privi Medical Pte, Ltd. · LKX Device, Thermal, Hemorrhoids
Cleared on Jan 10, 2018 as substantially equivalent to K981428 (Cryoptherapy Pain Relief Products, Inc., 1998) after a 160-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 10, 2018
- Review
- 160 days
- Class
- Class U
- Product code
- LKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981428 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981428 Anu IceCryoptherapy Pain Relief Products, Inc. · 1998
- This deviceK172358 InstaliefPrivi Medical Pte, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981428 | Anu Ice | Cryoptherapy Pain Relief Products, Inc. | 1998 | — |
| 0 (this device) | K172358 | Instalief | Privi Medical Pte, Ltd. | 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 LKX? 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 |
|---|---|---|---|
| * | K981428 | Anu IceSummary page 4…Amendment) 4. Predicate Device Information: Device Name: ANUICE Cryotherapy Pain Relief Products, Inc. Classification: Unclassified (Pre-Amendment) 510(k): K981428 Product Code: LKX 5. Submission Information: Date Summary Prepared: 11th July 2017 Prepared by: Prusothman M Sina Raja… | 1998 |
| † | K133393 | Gelpoint Path Transanal Access Platform | 2014 |
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.
- 2 other devices also cite its predicate K981428.
How does its category compare?
All LKX devicesLKX Device, Thermal, Hemorrhoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LKX
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LKX
Too few LKX 510(k)s in any year since 2007 to give a median.
Recalls per year · LKX
No recall names LKX since 2007.
Adverse event reports per year · LKX
1in 2023
MAUDE reports naming product code LKX, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 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 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues.
By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172358: Instalief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172358
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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