510(k) · Cleared
ClearedPressure Irrigating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Level 1 Technologies, Inc. · GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Cleared on May 12, 1994 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- May 12, 1994
- Review
- 134 days
- Class
- Class I
- Product code
- GCY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceK936223 Pressure Irrigating SystemLevel 1 Technologies, Inc. · 1994
- Descendant · cites it directly · 7 of its ownK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK262532 NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601…ICU Medical · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K072080 Normoflo Irrigation Fluid Warmer, Models H-1100…cites it directly · 2008
Most influential descendants
Showing 5 of 8 · See all- K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Smiths Medical Asd, Inc. · 2008 · cites it directly7descendants
- K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · 2 generations on4descendants
- K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · 3 generations on3descendants
- K172048FluidSmartThermedx, LLC · 2017 · 2 generations on2descendants
- K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936223 | Pressure Irrigating System | Level 1 Technologies, Inc. | 1994 | — |
| +1 | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation… | Smiths Medical Asd, Inc. | 2008 | Class I |
| +2 | K091939 | Thermedx Prodigy Fluid Management System, Models P1000, P2000 | Thermedx, LLC | 2010 | 2 |
| +3 | K133799 | Thermedx Fluid Managment System | Thermedx, LLC | 2014 | 2 |
| +2 | K172048 | FluidSmart | Thermedx, LLC | 2017 | 1 |
| +2 | K262532 | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501… | ICU Medical | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming… Class I | 2008 | 7 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K072080 (Smiths Medical Asd, Inc., 2008) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GCY devicesGCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCY
FDA has decided no GCY device since 2007.
Median 510(k) review, days · GCY
Too few GCY 510(k)s in any year since 2007 to give a median.
Recalls per year · GCY
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCY
178in 2025
MAUDE reports naming product code GCY, 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 | 246 |
| 2008 | 0 | — | 38 | 205 |
| 2009 | 0 | — | 2 | 231 |
| 2010 | 0 | — | 1 | 124 |
| 2011 | 0 | — | 12 | 58 |
| 2012 | 0 | — | 0 | 47 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 145 |
| 2017 | 0 | — | 0 | 260 |
| 2018 | 0 | — | 1 | 180 |
| 2019 | 0 | — | 0 | 200 |
| 2020 | 0 | — | 0 | 202 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 96 |
| 2023 | 0 | — | 0 | 90 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 0 | 178 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936223: Pressure Irrigating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936223
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026