510(k) · Cleared
Recalled · Class II · 2026Plaxtron Suction Unit, Model 88AA51/88AA61 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plaxtron Industrial (M) Sdn. Bhd. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Apr 3, 2012 as substantially equivalent to K982304 (Sunrise Medical Hhg, Inc., 1998) after an 85-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Apr 3, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- JCX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935218 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 1 generation backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- This deviceK120065 Plaxtron Suction Unit, Model 88AA51/88AA61 SeriesPlaxtron Industrial (M) Sdn. Bhd. · 2012
- Descendant · cites it directly · 0 of its ownK251111 CaryExcitus AS · 2025
Most influential descendants
Showing 1 of 1 · See all- K251111CaryExcitus AS · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −1 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| 0 (this device) | K120065 | Plaxtron Suction Unit, Model 88AA51/88AA61 Series | Plaxtron Industrial (M) Sdn. Bhd. | 2012 | — |
| +1 | K251111 | Cary | Excitus AS | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 JCX? 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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 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 |
|---|---|---|---|
| * | K982304 | Devilbiss Suction UnitSummary page 1…nit, Model 88 00 50 & 88 010 60, marketed name: Laerdal Compact Suction Unit (LCSU 3), 510(k) Number: K982304 PLAXTRON INDUSTRIAL (M) SDN. REID. PAGE 12 Plaxtron Suction Unit… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251111 | Cary | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2026 | Class II | Z-1341-2026 | Nonconforming Material/Component | units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M. |
| Dec 18, 2020 | Class II | Z-0868-2021 | Device Design | Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or… |
| Aug 31, 2017 | Class II | Z-0973-2018 | No Marketing Application | A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K251111 (Excitus AS, 2025) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K982304.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120065: Plaxtron Suction Unit, Model 88AA51/88AA61 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120065
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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