510(k) · Cleared
Recalled · Class II · 2016Delicot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Surgical Company, LLC · HBA Neurosurgical Paddie
Cleared on Sep 10, 2012 as substantially equivalent to K902921 (American Silk Sutures, Inc., 1990) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1986. It has been recalled 21 times.
- Decided
- Sep 10, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- HBA
- Recalls
- 21
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862494 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK862494 Polyester Sponge PattieAmerican Silk Sutures, Inc. · 1986 · Recalled
- This deviceK121822 DelicotAmerican Surgical Company, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862494 | Polyester Sponge Pattie | American Silk Sutures, Inc. | 1986 | 4 |
| 0 (this device) | K121822 | Delicot | American Surgical Company, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 HBA? 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 HBA device
- #1 K193346 Codman Surgical Patties & Stripsscore -1.6 · 1 generation · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902921 | Rayon Neurological SpongeSummary page 1…Product Code(s): HBA (neurosurgical paddie) Classification: Class 11 Current Levallv Marketed Device: Ray-Cot, Uniqcot and Delicot Neurosurgical Sponges K902921 American Surgical Company Special 1 5 10(k) Policot Neurosurgical Sponge K862494 Summary Description of the… | 1990 |
| * | K862494 | Polyester Sponge PattieSummary page 2…Marketed Device: Ray-Cot, Uniqcot and Delicot Neurosurgical Sponges K902921 American Surgical Company Special 1 5 10(k) Policot Neurosurgical Sponge K862494 Summary Description of the Device: The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2016 | Class II | Z-1785-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1784-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1787-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1721-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1775-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1780-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1779-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1791-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1792-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1781-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1722-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1786-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1789-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1783-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1793-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1790-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1776-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1782-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1777-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1778-2016 | Packaging process control | Product packaging defective compromising sterility |
| Mar 31, 2016 | Class II | Z-1788-2016 | Packaging process control | Product packaging defective compromising sterility |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All HBA devicesHBA Neurosurgical Paddie: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HBA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HBA
Too few HBA 510(k)s in any year since 2007 to give a median.
Recalls per year · HBA
23in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBA
5in 2025
MAUDE reports naming product code HBA, 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 | — | 0 | 12 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 3 | 25 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 1 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 40 |
| 2017 | 0 | — | 0 | 35 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 0 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 44 |
| 2022 | 0 | — | 1 | 28 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 23 | 27 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The device is a neurosurgical pad~ used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121822: Delicot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121822
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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