510(k) Report

510(k) · Cleared

Cleared

Suboccipital Ice Pillow

K882413510(k) TraditionalCleared Nov 30, 1988170-day reviewClass I21 CFR 890.5700

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

Ferguson Medical · IME Pack, Hot Or Cold, Reusable

Cleared on Nov 30, 1988 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 30, 1988
Review
170 days
Class
Class I
Product code
IME
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K882413Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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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?

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.

How does its category compare?

All IME devices

IME Pack, Hot Or Cold, Reusable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IME

FDA has decided no IME device since 2007.

Median 510(k) review, days · IME

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

Recalls per year · IME

1in 2025

2012: 12021: 12022: 82025: 1
2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · IME

6in 2025

2007: 32008: 72009: 112010: 62011: 92012: 52013: 92014: 82015: 112016: 242017: 152018: 172019: 112020: 92021: 62022: 62023: 52024: 122025: 6
2007high 24 (2016) · low 3 (2007)2025

MAUDE reports naming product code IME, 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—03
20080—07
20090—011
20100—06
20110—09
20120—15
20130—09
20140—08
20150—011
20160—024
20170—015
20180—017
20190—011
20200—09
20210—16
20220—86
20230—05
20240—012
20250—16
20260—0—

More from Ferguson Medical

57 FDA decisions under this applicant name. See the company

  • K033153Dicom TheaterFerguson Medical · 2004
  • K962615Tumorlocalizer MriFerguson Medical · 1998
  • K963794PunctureneedleFerguson Medical · 1998
  • K971813EMBLAFerguson Medical · 1998
  • K972217Orthopedic Screw SystemFerguson Medical · 1997

Recent decisions in IME

The IME category page

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  • K915876HotpadTen Comfort Corp. · 1993
  • K921446Hot or Cold Pack (Thermipaq)Thermionics Corp. · 1992
  • K905207Micro-Aire Soft-Ice, Cold Therapy CompressMicro Surgical Instruments Corp. · 1991
  • K863654RE-Heater, Hot PackK & L Ent. · 1986

https://510kreport.com/device/K882413 · printed Nov 5, 2026

Cite this page

510(k) Report. “K882413: Suboccipital Ice Pillow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882413

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