510(k) · Cleared
ClearedHistobrush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Medical Products Company, LLC · HHT Spatula, Cervical, Cytological
Cleared on Jan 19, 2012 as substantially equivalent to K874604 (Spectrum Co., 1988) and 1 other predicate after a 218-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 19, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874604 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK874604 HistobrushSpectrum Co. · 1988
- This deviceK111681 HistobrushPuritan Medical Products Company, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874604 | Histobrush | Spectrum Co. | 1988 | — |
| 0 (this device) | K111681 | Histobrush | Puritan Medical Products Company, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 HHT? 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 |
|---|---|---|---|
| * | K874604 | HistobrushSummary page 1…ogy brush Classification name: Cytological endocervical brush 3. Predicate Devices: Histobrush, Spectrum Companies, K874604 Cell Collecting Brush, Anderson Winn, K924908 4. Device descript… | 1988 |
| * | K924908 | Cell Collecting BrushSummary page 1…3. Predicate Devices: Histobrush, Spectrum Companies, K874604 Cell Collecting Brush, Anderson Winn, K924908 4. Device description: The Puritan Histobrush consists of nylon bristles secured b… | 1993 |
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 HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HHT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · HHT
Too few HHT 510(k)s in any year since 2007 to give a median.
Recalls per year · HHT
No recall names HHT since 2007.
Adverse event reports per year · HHT
1in 2025
MAUDE reports naming product code HHT, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To obtain endocervical cells for Pap smear cytology test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111681: Histobrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111681
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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