510(k) · Cleared
ClearedNorapad Plain; Norapad TA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perlei Medical, Inc. · HBA Neurosurgical Paddie
Cleared on Mar 27, 2002 as substantially equivalent to K993019 (V. Mueller Neuro/Spine, 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Mar 27, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HBA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993019 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK993019 Pacific Surgical PattiesV. Mueller Neuro/Spine · 2000
- This deviceK014268 Norapad Plain; Norapad TAPerlei Medical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993019 | Pacific Surgical Patties | V. Mueller Neuro/Spine | 2000 | — |
| 0 (this device) | K014268 | Norapad Plain; Norapad TA | Perlei Medical, Inc. | 2002 | — |
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? (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 |
|---|---|---|---|
| * | K993019 | Pacific Surgical PattiesSummary page 1…sification Name: Tape and bandage, Adhesive Device Name: Paddie, Cottonoid Proprietary Name: Norapad Regulatory Class: I Classification Number: HBA Predicate Device: K993019 Pacific Surgical Patties Pacific Surgical Innovations, Inc Intended Use: Intcnded for neurosurgical procedures to protect tissue… | 2000 |
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.
- 1 other device also cites its predicate K993019.
How does its category compare?
All HBA devicesHBA Neurosurgical Paddie: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the uscr in sterile packages. These patties are X-ray detectable and are provided in 2 Variety of sizes necessary to meet clinical needs.
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/K014268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014268: Norapad Plain; Norapad TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014268
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026