510(k) · Cleared
ClearedAhlstrom Grade 226 Specimen Collection Paper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ahlstrom Mount Holly Springs, LLC · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Oct 19, 2007 as substantially equivalent to K932661 (Whatman Specialty Products, Inc., 1996) after a 386-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Oct 19, 2007
- Review
- 386 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932661 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK932661 Whatman Body Fluid Collection Paper:Whatman BFC180Whatman Specialty Products, Inc. · 1996 · Recalled
- This deviceK062932 Ahlstrom Grade 226 Specimen Collection PaperAhlstrom Mount Holly Springs, LLC · 2007
- Descendant · cites it directly · 0 of its ownK121864 Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K121864Perkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932661 | Whatman Body Fluid Collection Paper:Whatman BFC180 | Whatman Specialty Products, Inc. | 1996 | 3 |
| 0 (this device) | K062932 | Ahlstrom Grade 226 Specimen Collection Paper | Ahlstrom Mount Holly Springs, LLC | 2007 | — |
| +1 | K121864 | Perkinelmer 226 Sample Collection Devices | Perkinelmer, Inc. | 2013 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 JKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K932661 | Whatman Body Fluid Collection Paper:Whatman BFC180Summary page 1…: II Product code: JKA Applicable CFR Section : 21 CFR 862.1675: Blood specimen collection device Predicate device; Whatman Body Fluid Collection Paper: Whatman BFC 18. K932661 Device description: Ahlstrom 226 specimen collection paper is designed to provide a uniform surface for - the collection of blo… | 1996 |
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 |
|---|---|---|---|
| K121864 | Perkinelmer 226 Sample Collection Devices | 2013 | 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?
- Its one ancestor has a recall.
- Of its descendants, K121864 (Perkinelmer, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
Ahlstrom 226 specimen collection paper is intended to be used as a medium to collect and transport blood specimen spots to a laboratory. The 226 paper will be in the format of a printed card that may be incorporated along with a tear-apart form for demographic information.
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/K062932 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062932: Ahlstrom Grade 226 Specimen Collection Paper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062932
Report an extraction error
Are you the manufacturer?
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