510(k) · Cleared
ClearedHemaway Seat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemaway, LLC · LRL Cushion, Hemorrhoid
Cleared on Dec 7, 2007 as substantially equivalent to K864470 (Health Aid Products, 1987) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Dec 7, 2007
- Review
- 74 days
- Class
- Class U
- Product code
- LRL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K821860 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK821860 BK-6477 the Derby Raised Toilet SeatFred Sammons, Inc. · 1982
- This deviceK072690 Hemaway SeatHemaway, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821860 | BK-6477 the Derby Raised Toilet Seat | Fred Sammons, Inc. | 1982 | — |
| 0 (this device) | K072690 | Hemaway Seat | Hemaway, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 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 LRL? 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? (2)
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 |
|---|---|---|---|
| * | K864470 | Hemorest (TM)Summary page 8…of Device Evaluation (ODE) 7 Section D: Substantial Equivalence Predicate Devices: HemorestTM (K864470) The Derby Raised Toilet Seat (K821860) Narrative Description of Substantial Equivalence: The Hemaway… | 1987 |
| * | K821860 | BK-6477 the Derby Raised Toilet SeatSummary page 8…7 Section D: Substantial Equivalence Predicate Devices: HemorestTM (K864470) The Derby Raised Toilet Seat (K821860) Narrative Description of Substantial Equivalence: The Hemaway Seat is substantially equivalent to other FDA listed and 510(k)… | 1982 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LRL devicesLRL Cushion, Hemorrhoid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LRL
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · LRL
Too few LRL 510(k)s in any year since 2007 to give a median.
Recalls per year · LRL
No recall names LRL since 2007.
Adverse event reports per year · LRL
No MAUDE report names LRL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 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 Hemaway Seat is for the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only.
The Hemaway Seat is for the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072690 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072690: Hemaway Seat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072690
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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