510(k) · Cleared
ClearedPuritan Foam Tip Swab Model 2197
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hardwood Products Co., LP · HHT Spatula, Cervical, Cytological
Cleared on Jul 9, 1996 after a 53-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Jul 9, 1996
- Review
- 53 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 2
1 later device descends from it, 1 citing it directly.
- This deviceK961934 Puritan Foam Tip Swab Model 2197Hardwood Products Co., LP · 1996
- Descendant · cites it directly · 0 of its ownK083012 PapconeOtto Bock Pur Life Science GmbH · 2009
Most influential descendants
Showing 1 of 1 · See all- K083012PapconeOtto Bock Pur Life Science GmbH · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961934 | Puritan Foam Tip Swab Model 2197 | Hardwood Products Co., LP | 1996 | — |
| +1 | K083012 | Papcone | Otto Bock Pur Life Science GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K902338 | Absorbent Tip Applicator Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ab/applicator RES T ~ Clagsification Name: Cervical cytological spatula Ty N R S L&P Lo 4. Predicate Devices: Absorbent Tip Applicator (Hardwood AJ*‘\} « Products Co. K902338) N & h Cell Collecting Brush (Anderson Winn Paper \5 Co. K524508) ) ] 4 b The Puritan Foam Tip Swab consists of a polyurethan… | |
| Kept off the family tree | K524508 | Cell Collecting Brush Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…tula Ty N R S L&P Lo 4. Predicate Devices: Absorbent Tip Applicator (Hardwood AJ*‘\} « Products Co. K902338) N & h Cell Collecting Brush (Anderson Winn Paper \5 Co. K524508) ) ] 4 b The Puritan Foam Tip Swab consists of a polyurethane foam tip bonded to a high impact polystyrene shaft with hot melt… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083012 | Papcone | 2009 | 0 |
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?
- Of its descendants, K083012 (Otto Bock Pur Life Science GmbH, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961934: Puritan Foam Tip Swab Model 2197.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961934
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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