510(k) · Cleared
ClearedAmt Nanocath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Technologies, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on May 27, 2005 as substantially equivalent to K023140 (Epimed International, Inc., 2003) and 5 other predicates after an 85-day review. Its family tree reaches back 6 generations to 1990. 1 of the 24 devices in its family, counting itself, has a Class I recall.
- Decided
- May 27, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K896422 (1990). 23 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 4 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 3 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 2 generations backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- 1 generation backK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- This deviceK050557 Amt NanocathAmerican Medical Technologies, Inc. · 2005
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −5 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −4 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −3 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −2 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| −1 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| 0 (this device) | K050557 | Amt Nanocath | American Medical Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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.
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.
Top candidate predicates for a new BSO device
- #1 K241410 EDEN ControlCathscore 9.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K023140 | Versa-Kath Epidural Catheter, Model 156-2124Summary page 1…fatigue tests and shown equivalent. VI. Substantial Equivalence: The AMT NanoCathTm is substantially equivalent to the Versa-Kath Epidural Catheter cleared by Epimed in K023 140, has the same use, and was subjected to similar bench testing which confirmed that the performance is equivalent, The NanoCath~m… | 2003 |
| * | K981329 | Feth-R-KathSummary page 1…and was subjected to similar bench testing which confirmed that the performance is equivalent, The NanoCath~m is also equivalent to the Feth-R-Cath cleared by Epimed in K98 1329. It is manufactured very similarly to the Perifix FX by Braun (several 5 10(k)s, e.g.K042488, K033952) and is equivalent to this… | 1998 |
| * | K042488 | Perifix Catheter and Contiplex CatheterSummary page 1…, The NanoCath~m is also equivalent to the Feth-R-Cath cleared by Epimed in K98 1329. It is manufactured very similarly to the Perifix FX by Braun (several 5 10(k)s, e.g.K042488, K033952) and is equivalent to this device. The AMT NanoCathTm is substantially equivalent as well to older epidural catheters su… | 2004 |
| * | K033952 | Perifix Catheter ConnectorSummary page 1…oCath~m is also equivalent to the Feth-R-Cath cleared by Epimed in K98 1329. It is manufactured very similarly to the Perifix FX by Braun (several 5 10(k)s, e.g.K042488, K033952) and is equivalent to this device. The AMT NanoCathTm is substantially equivalent as well to older epidural catheters such as the… | 2004 |
| * | K991879 | Spring-Wound Epidural CatheterSummary page 1…ivalent to this device. The AMT NanoCathTm is substantially equivalent as well to older epidural catheters such as the Spring-Wound Epidural Catheter cleared by Micor in K991879 and the Racz Epidural Catheter cleared in K954584. (cont' d) T… | 1999 |
| * | K954584 | Racz Epidural CatheterSummary page 1…tantially equivalent as well to older epidural catheters such as the Spring-Wound Epidural Catheter cleared by Micor in K991879 and the Racz Epidural Catheter cleared in K954584. (cont' d) The NanoCath also is manufactured very similarly to… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K023140.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
The AMT NanoCathTM epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural caudal anesthesia for up to 72 hours
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050557: Amt Nanocath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050557
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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