510(k) · Cleared
ClearedModification to Personal Infusor Local Pain Management Procedural Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Science Incorporated · FRN Pump, Infusion
Cleared on Mar 27, 2002 as substantially equivalent to K010824 (Science Incorporated, 2001) after a 9-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Mar 27, 2002
- Review
- 9 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010824 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010824 Personal Infusor Local Pain Management Procedural KitScience Incorporated · 2001
- This deviceK020881 Modification to Personal Infusor Local Pain Management Procedural KitScience Incorporated · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010824 | Personal Infusor Local Pain Management Procedural Kit | Science Incorporated | 2001 | — |
| 0 (this device) | K020881 | Modification to Personal Infusor Local Pain Management Procedural Kit | Science Incorporated | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K010824 | Personal Infusor Local Pain Management Procedural KitSummary page 1…p Classification name: Infusion pump Predicate device: Science Incorporated Personal Infusor Local Pain Management Procedural Kit manufactured by Science Incorporated (K010824) Device description: The Science Incorporated Personal Infusor Local Pain Management Procedural Kit consists of a Personal Infu… | 2001 |
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 FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications direcdy into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor’s administration line, which is attached to a catheter. The Personal Infusor is portable and is suitable for use by ambulatory…
Read the full statement (109 words)
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications direcdy into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor’s administration line, which is attached to a catheter.
The Personal Infusor is portable and is suitable for use by ambulatory patients.
The Personal Infusor is intended for single use only.
The Personal Infusor is not intended for rapid infusion, intravenous or intra-arterial drug infusion, for the delivery of blood, blood products, lipids, or fat emulsions, or for use by patients with a history of allergic reactions to anesthetics.
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/K020881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020881: Modification to Personal Infusor Local Pain Management Procedural Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020881
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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