510(k) · Cleared
ClearedImpact Model 323 Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impact Instrumentation, Inc. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Mar 10, 2014 as substantially equivalent to K061133 (Novaspine, LLC, 2006) and 1 other predicate after a 144-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 10, 2014
- Review
- 144 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935218 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
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) | K133196 | Impact Model 323 Aspirator | Impact Instrumentation, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K061133 | Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SSummary page 1…Registration Number: 2242630 4. Predicate Device: The predicate device is the: * Simex AC30 and DC3O (K061133) marketed by NovaSpine LLC. * DeVilbiss 7305P (K982304) marketed by DeVilb… | 2006 |
| * | K982304 | Devilbiss Suction UnitSummary page 1…ce is the: * Simex AC30 and DC3O (K061133) marketed by NovaSpine LLC. * DeVilbiss 7305P (K982304) marketed by DeVilbiss Healthcare LLC.… | 1998 |
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 20 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K061133.
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. 2014, 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 IMPACT® Model 323 Aspirator is a self-contained suction apparatus designed for
use in removing debris from a patient's airway or respiratory system, secretions, blood,
vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials
from wounds, either during surgery or at the patient's bedside. It is suitable for use in
pre-hospital, hospital, mass casualty and transport environments. The Model 323 is
only for use by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133196: Impact Model 323 Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133196
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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