510(k) Report

510(k) · Cleared

Cleared

MTC XI UL

K871178510(k) TraditionalCleared Oct 9, 1987199-day reviewClass II21 CFR 880.5130

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

Aragona Medical, Inc. · FMT Warmer, Infant Radiant

Cleared on Oct 9, 1987 after a 199-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 323 later devices descend from it.

Decided
Oct 9, 1987
Review
199 days
Class
Class II
Product code
FMT
Recalls
None
Predicates
0

323 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2003: 3 descendants cleared2004: 2 descendants cleared2007: 3 descendants cleared2008: 11 descendants cleared2005: 4 descendants cleared2009: 4 descendants cleared2010: 6 descendants cleared2006: 2 descendants cleared2011: 5 descendants cleared2020: 28 descendants cleared2019: 17 descendants cleared2018: 17 descendants cleared2014: 8 descendants cleared2012: 4 descendants cleared2015: 14 descendants cleared2013: 4 descendants cleared2016: 16 descendants cleared2022: 31 descendants cleared2017: 12 descendants cleared2025: 38 descendants cleared2021: 22 descendants cleared2024: 30 descendants cleared2026: 20 descendants cleared2023: 21 descendants cleared1990200020102020
  1. This deviceK871178 MTC XI ULAragona Medical, Inc. · 1987
  2. Descendant · cites it directly · 322 of its ownK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
  3. Descendant · 2 generations on · 295 of its ownK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
  4. Descendant · 3 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
  5. Descendant · 4 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
  6. Descendant · 4 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005

Showing 5 of 323 descendants. See all descendants

Descendants cleared per year

1998: 12003: 32004: 22005: 42006: 22007: 32008: 112009: 42010: 62011: 52012: 42013: 42014: 82015: 142016: 162017: 122018: 172019: 172020: 282021: 222022: 312023: 212024: 302025: 382026: 20
1998high 38 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 323 · See all
  • K982636Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998 · cites it directly322descendants
  • K022609Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003 · 2 generations on295descendants
  • K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 3 generations on294descendants
  • K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 4 generations on241descendants
  • K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 4 generations on239descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871178MTC XI ULAragona Medical, Inc.1987—
+1K982636Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd.1998—
+2K022609Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd.2003—
+3K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004—
+4K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20041
+4K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200330
200420
200540
200620
200730
2008110
200940
201060
201150
201240
201340
201480
2015140
2016160
2017120
2018170
2019170
2020280
2021220
2022310
2023210
2024300
2025380
2026200
FIG. 1 — Lineage of K871178, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in FMT? 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 FMT device

  1. #1 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (323)

See all 323

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

NumberDeviceApplicantDecidedDescendants
K982636Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd.1998322

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, K982636 (Fisher & Paykel Healthcare, Ltd., 1998) has gone furthest, with 322 descendants of its own.

How does its category compare?

All FMT devices

FMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMT

1in 2025

2007: 22009: 12010: 12011: 12012: 42013: 12018: 12020: 22021: 12022: 12023: 12025: 1
2007high 4 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMT

103in 2012

2012: 103 days median
2007high 103 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMT

4in 2019

2008: 12009: 22013: 22014: 12015: 12016: 12018: 42019: 4, 4 Class I2026 (partial year): 2, 2 Class I
2007high 4 (2018) · low 0 (2007)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · FMT

359in 2025

2007: 212008: 1142009: 802010: 1062011: 792012: 542013: 552014: 792015: 562016: 562017: 462018: 792019: 1,4372020: 1,6052021: 4732022: 1532023: 1752024: 2572025: 359
2007high 1,605 (2020) · low 21 (2007)2025

MAUDE reports naming product code FMT, 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
20072—021
20080—1114
20091—280
20101—0106
20111—079
20124103054
20131—255
20140—179
20150—156
20160—156
20170—046
20181—479
20190—4 (4)1,437
20202—01,605
20211—0473
20221—0153
20231—0175
20240—0257
20251—0359
20260—2 (2)—

More from Aragona Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K871177NTH 101 ULAragona Medical, Inc. · 1987

Recent decisions in FMT

The FMT category page

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https://510kreport.com/device/K871178 · printed Nov 6, 2026

Cite this page

510(k) Report. “K871178: MTC XI UL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871178

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026