510(k) · Cleared
ClearedJJ Skinner Carekits Minor Surgical Procedure Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J.J. Skinner, Inc. · LRO General Surgery Tray
Cleared on May 10, 1996 as substantially equivalent to K903545 (J.J. Skinner, Inc., 1990) after a 9-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 10, 1996
- Review
- 9 days
- Class
- Class II
- Product code
- LRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903545 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK903545 Carekits (TM), IV/Cath/Cent Line Dress/TPN/CVP KitsJ.J. Skinner, Inc. · 1990
- This deviceK961683 JJ Skinner Carekits Minor Surgical Procedure TrayJ.J. Skinner, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903545 | Carekits (TM), IV/Cath/Cent Line Dress/TPN/CVP Kits | J.J. Skinner, Inc. | 1990 | — |
| 0 (this device) | K961683 | JJ Skinner Carekits Minor Surgical Procedure Tray | J.J. Skinner, Inc. | 1996 | — |
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 LRO? 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 LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.4 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K903545 | Carekits (TM), IV/Cath/Cent Line Dress/TPN/CVP KitsSummary page 2…Procedure Tray/Kit is substantially equivalent in intended use and contents to trays legally ma-keted. Several companies including JJ Skinner’s CareKits™ approved under K903545. Intended Use of the Subject Devices: The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Heal… | 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 LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
MAUDE reports naming product code LRO, 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 | — | 1 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
What is it indicated for?
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.
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/K961683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961683: JJ Skinner Carekits Minor Surgical Procedure Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961683
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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