510(k) · Cleared
ClearedSterile Tracheostomy Care Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Pak · KDD Kit, Surgical Instrument, Disposable
Cleared on Jun 16, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Jun 16, 1982
- Review
- 28 days
- Class
- Class I
- Product code
- KDD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK821501 Sterile Tracheostomy Care KitPro-Pak · 1982
- Descendant · cites it directly · 0 of its ownK984187 Crosstex Non-Woven SpongesCrosstex Intl. · 1999 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K984187Crosstex Non-Woven SpongesCrosstex Intl. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821501 | Sterile Tracheostomy Care Kit | Pro-Pak | 1982 | — |
| +1 | K984187 | Crosstex Non-Woven Sponges | Crosstex Intl. | 1999 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KDD? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K984187 | Crosstex Non-Woven Sponges | 1999 | 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, K984187 (Crosstex Intl., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KDD devicesKDD Kit, Surgical Instrument, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDD
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDD
Too few KDD 510(k)s in any year since 2007 to give a median.
Recalls per year · KDD
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDD
33in 2025
MAUDE reports naming product code KDD, 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 | 0 | — | 2 | 0 |
| 2008 | 1 | — | 5 | 0 |
| 2009 | 0 | — | 7 | 0 |
| 2010 | 0 | — | 4 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 25 |
| 2015 | 0 | — | 3 | 54 |
| 2016 | 0 | — | 0 | 33 |
| 2017 | 0 | — | 2 | 12 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 22 |
| 2020 | 0 | — | 0 | 44 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 1 | 12 |
| 2023 | 0 | — | 1 | 43 |
| 2024 | 0 | — | 5 | 58 |
| 2025 | 0 | — | 1 | 33 |
| 2026 | 0 | — | 12 (1) | — |
https://510kreport.com/device/K821501 · printed Nov 5, 2026
Cite this page
510(k) Report. “K821501: Sterile Tracheostomy Care Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K821501
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026