510(k) · Cleared
ClearedDisposable Cervical Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Hls Medical Products Co., Ltd. · HHT Spatula, Cervical, Cytological
Cleared on May 14, 2015 as substantially equivalent to K896065 (Wallach Surgical Devices, Inc., 1990) after a 385-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 14, 2015
- Review
- 385 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896065 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896065 Wallach CC/BrushWallach Surgical Devices, Inc. · 1990
- This deviceK141057 Disposable Cervical BrushNingbo Hls Medical Products Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896065 | Wallach CC/Brush | Wallach Surgical Devices, Inc. | 1990 | — |
| 0 (this device) | K141057 | Disposable Cervical Brush | Ningbo Hls Medical Products Co., Ltd. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K896065 | Wallach CC/BrushSummary page 4…Gynecologic Specialized Manual Instrument (21 CFR 884.4530) Regulation class: II Product Code: HHT (Spatula, Cervical, Cytological) Predicate Device: Wallach CC/Brush (K896065) Device Description: The Disposable Cervical Brush is a non-sterile, disposable, colored cytological cervical spatula intended… | 1990 |
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 HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods.
It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141057: Disposable Cervical Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141057
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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