510(k) · Cleared
ClearedPain Control Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgarlato Laboratories, Inc. · FRN Pump, Infusion
Cleared on Mar 19, 1999 as substantially equivalent to K896422 (Burron Medical, Inc., 1990) after a 66-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it.
- Decided
- Mar 19, 1999
- Review
- 66 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896422 (1990). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- This deviceK990101 Pain Control Infusion PumpSgarlato Laboratories, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK992551 Alpha Infusion PumpAdvanced Infusion, Inc. · 1999
- Descendant · 2 generations on · 4 of its ownK021964 Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK042246 Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK071532 Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K992551Alpha Infusion PumpAdvanced Infusion, Inc. · 1999 · cites it directly5descendants
- K021964Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002 · 2 generations on4descendants
- K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004 · 3 generations on1descendant
- K071532Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008 · 3 generations on0descendants
- K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| 0 (this device) | K990101 | Pain Control Infusion Pump | Sgarlato Laboratories, Inc. | 1999 | — |
| +1 | K992551 | Alpha Infusion Pump | Advanced Infusion, Inc. | 1999 | — |
| +2 | K021964 | Alpha Infusion Pump and Catheters | Advanced Infusion, Inc. | 2002 | — |
| +3 | K042246 | Multi-Drip Infusion Catheter | Advanced Infusion, Inc. | 2004 | — |
| +3 | K071532 | Alpha Infusion Pump, Model A200, A450 | Advanced Infusion, Inc. | 2008 | — |
| +3 | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K896422 | Burron Ambulatory Drug Delivery SystemSummary page 1…device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories b… | 1990 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.
The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.
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/K990101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990101: Pain Control Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990101
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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