510(k) Report

510(k) · Cleared

Cleared

Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube Set

K091441510(k) TraditionalCleared Oct 30, 2009168-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synergetics, Inc. · FRN Pump, Infusion

Cleared on Oct 30, 2009 as substantially equivalent to K990518 (Peregrine Surgical, Ltd., 1999) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1991.

Decided
Oct 30, 2009
Review
168 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K911808 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK911808 · Gemini Ophthalmic Surgery System · Alcon Laboratories · 1991 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K911808 · Gemini Ophthalmic Surgery System · Alcon Laboratories · 1991 · recalled0
  1. Root · 1 generation backK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991 · Recalled
  2. This deviceK091441 Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetSynergetics, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911808Gemini Ophthalmic Surgery SystemAlcon Laboratories19912
0 (this device)K091441Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetSynergetics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K091441, 1991–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K990518Peregrine Wet Set, Model PD400.00
Summary page 1
…Product Code: FRN FDA Panel: Ophthalmic Predicate Device: Peregrine Wet Set, K9905 18 Intended Use! Device Description: The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air…
Peregrine Surgical, Ltd.1999—
*K911808Gemini Ophthalmic Surgery System
Summary page 2
…Peregrine Wet Set Alcon VGFI Tube Set AGPI Tube Set K990518 K911808 Indications for Use Pressured Air Delivered from Bottle Bottle/ system console Bottle/ system cons…
Alcon Laboratories19912

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?

  • 1 of the 2 ancestors has a recall of any class.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

Indications for use as stated in the FDA summary.

More from Synergetics, Inc.

16 FDA decisions under this applicant name. See the company

  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 201219 recalls
  • K121675VersavitSynergetics, Inc. · 20124 recalls
  • K113857Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 2012
  • K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 20113 recalls
  • K071482Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. · 20071 recall

Recent decisions in FRN

The FRN category page

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https://510kreport.com/device/K091441 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091441: Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091441

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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