510(k) · Cleared
ClearedSgarlato Labs Painfree Pump and Pain 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 30, 2005 as substantially equivalent to K984146 (I-Flow Corp., 1999) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Mar 30, 2005
- Review
- 132 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896422 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 2 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 1 generation backK984146 Paragon InfusionI-Flow Corp. · 1999
- This deviceK043204 Sgarlato Labs Painfree Pump and Pain Control Infusion PumpSgarlato Laboratories, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −3 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −2 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −1 | K984146 | Paragon Infusion | I-Flow Corp. | 1999 | — |
| 0 (this device) | K043204 | Sgarlato Labs Painfree Pump and Pain Control Infusion Pump | Sgarlato Laboratories, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K984146 | Paragon InfusionSummary page 1…ernative administration routes should be considered substantially equivalent to currently cleared predicate devices. Predicate Devices cited are the Paragon Infusion Kit K984146 and the Sgarlato Pain Control Infusion Pump K990101. Similarities This infusion pump is one of a multiplicity of similar general… | 1999 |
| * | K990101 | Pain Control Infusion PumpSummary page 1…substantially equivalent to currently cleared predicate devices. Predicate Devices cited are the Paragon Infusion Kit K984146 and the Sgarlato Pain Control Infusion Pump K990101. Similarities This infusion pump is one of a multiplicity of similar general purpose devices marketed to provide continuous infu… | 1999 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K984146.
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 Sgarlato PainFree Pump is a single use, general purpose infusion device intended to provide continuous infusion of medication (such as local anesthetics or corticosteroids) directly into a target site for the purpose of pain relief. Infusion may be carried out via percutaneous, subcutaneous, and epidural routes. The PainFree Pump may be used to provide continuous infusion of a local anesthetic directly into an intraoperative site for postoperative management of pain following surgery. It is suitable for use as an ambulatory device. It is not intended for vascular drug delivery, hyperalimentation, or the delivery of blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043204: Sgarlato Labs Painfree Pump and Pain Control Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043204
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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