510(k) Report

510(k) · Cleared

Cleared

Astoflo

K020060510(k) AbbreviatedCleared Mar 5, 200256-day reviewClass II21 CFR 864.9205

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nats Corp. · BSB Warmer, Blood, Non-Electromagnetic Radiation

Cleared on Mar 5, 2002 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Mar 5, 2002
Review
56 days
Class
Class II
Product code
BSB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared200020052010201520202025
  1. This deviceK020060 AstofloNats Corp. · 2002
  2. Descendant · cites it directly · 0 of its ownK082765 Astoflo PlusStihler Electronic GmbH · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K082765Astoflo PlusStihler Electronic GmbH · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020060AstofloNats Corp.2002—
+1K082765Astoflo PlusStihler Electronic GmbH2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K020060, 2002–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BSB? 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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082765Astoflo PlusStihler Electronic GmbH20080

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?

  • Of its descendants, K082765 (Stihler Electronic GmbH, 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BSB devices

BSB Warmer, Blood, Non-Electromagnetic Radiation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSB

1in 2011

2009: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSB

Too few BSB 510(k)s in any year since 2007 to give a median.

Recalls per year · BSB

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BSB

197in 2025

2007: 42008: 52010: 62011: 352012: 42013: 52014: 102015: 112016: 662017: 292018: 362019: 1472020: 2162021: 3402022: 4472023: 2902024: 2822025: 197
2007high 447 (2022) · low 0 (2009)2025

MAUDE reports naming product code BSB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20080—05
20091—00
20100—06
20111—035
20120—04
20130—05
20140—110
20150—011
20160—066
20170—029
20180—036
20190—0147
20200—0216
20210—0340
20220—0447
20230—0290
20240—0282
20250—0197
20260—0—

What is it indicated for?

1. Warming transfusions, infusions, fluids.

2. Warming blood infusions and return blood flow.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Nats Corp.

5 FDA decisions under this applicant name. See the company

  • K040143MonorailNats Corp. · 2004
  • K033142Powered WheelchairNats Corp. · 2004
  • K011820Dentorium Convertible AcrylicNats Corp. · 2001
  • K991184Hydrotone-Thermal Capsule SystemNats Corp. · 1999

Recent decisions in BSB

The BSB category page

  • K112639The Belmont Buddy Lite Fluid WarmerBelmont Instrument Corp. · 2011
  • K090508The Belmont Buddy Lite Fluid WarmerBelmont Instrument Corp. · 2009
  • K062774Belmont Buddy Plus Fluid WarmerBelmont Instrument Corp. · 2006
  • K052547Belmont Buddy Fluid WarmerBelmont Instrument Corp. · 2005
  • K031478MicroheaterBelmont Instrument Corp. · 2003

https://510kreport.com/device/K020060 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020060: Astoflo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020060

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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