# K961934: Puritan Foam Tip Swab Model 2197

- Pathway: 510(k) (Traditional)
- Applicant: Hardwood Products Co., LP
- Decided: Jul 9, 1996 after 53 days
- Product code: HHT (Spatula, Cervical, Cytological)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but 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.
- 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.

## Most influential descendants
- K083012: Papcone (2009), 0 descendants of its own

## Indications for use
The Puritan Foam Tip Swab is used to obtain a Pap smear sample from the endocervix.

Source page: https://510kreport.com/device/K961934
Methodology: https://510kreport.com/methodology