510(k) · Cleared
ClearedSafePort (TM) Manifold (or Stopcock)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcam Medical Acal · FMG Stopcock, I.V. Set
Cleared on Sep 15, 2022 as substantially equivalent to K060231 (Elcam Medical Acal, 2006) after a 511-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Sep 15, 2022
- Review
- 511 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862691 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK862691 StopcockRam Development · 1986
- 2 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 1 generation backK060231 Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated…Elcam Medical Acal · 2006 · Recalled
- This deviceK211204 SafePort (TM) Manifold (or Stopcock)Elcam Medical Acal · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862691 | Stopcock | Ram Development | 1986 | — |
| −2 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −1 | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated… | Elcam Medical Acal | 2006 | 20 |
| 0 (this device) | K211204 | SafePort (TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022 | — |
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 FMG? 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 FMG device
- #1 K242255 Qitexio® 4-Way Stopcock (QIT014)score 10.5 · 5 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 |
|---|---|---|---|
| * | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockSummary page 4…ation of Predicate Devices 3.1. Primary Predicate Device: Closed Swabable Stopcock and Minimal Residual Volume Luer-activated Swabable-stopcock, cleared under K060231 on April 13, 2006. 3.2. Reference Device: SafePort ManifoldTM (or Stopcock), cleared under 510(k) number K111016 on Ju… | 2006 |
| † | K111016 | Safeport Manifold (TM) (or Stopcock) | 2011 |
| † | K032393 | Induction and Sampling Manifold (or Stopcock) | 2003 |
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 36 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 3 other devices also cite its predicate K060231.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMG
Too few FMG 510(k)s in any year since 2007 to give a median.
Recalls per year · FMG
33in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMG
868in 2025
MAUDE reports naming product code FMG, 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 | 2 | — | 5 | 26 |
| 2008 | 2 | — | 4 | 48 |
| 2009 | 2 | — | 0 | 27 |
| 2010 | 0 | — | 2 | 131 |
| 2011 | 0 | — | 8 | 95 |
| 2012 | 0 | — | 0 | 93 |
| 2013 | 2 | — | 0 | 117 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 96 |
| 2016 | 0 | — | 1 | 148 |
| 2017 | 0 | — | 2 | 114 |
| 2018 | 1 | — | 3 | 164 |
| 2019 | 2 | — | 0 | 400 |
| 2020 | 0 | — | 5 | 284 |
| 2021 | 0 | — | 0 | 245 |
| 2022 | 2 | — | 0 | 280 |
| 2023 | 2 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 935 |
| 2025 | 1 | — | 33 (1) | 868 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211204: SafePort (TM) Manifold (or Stopcock).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211204
Report an extraction error
Are you the manufacturer?
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