510(k) Report

510(k) · Cleared

Cleared

Blakemore Retainer

K880253510(k) TraditionalCleared Mar 11, 198851-day reviewClass II21 CFR 876.5980

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

Orthopedic Systems, Inc. · FEF Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

Cleared on Mar 11, 1988 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 11, 1988
Review
51 days
Class
Class II
Product code
FEF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K880253Source: 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.

Planning a device in FEF? 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 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 FEF devices

FEF Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEF

FDA has decided no FEF device since 2007.

Median 510(k) review, days · FEF

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

Recalls per year · FEF

No recall names FEF since 2007.

Adverse event reports per year · FEF

No MAUDE report names FEF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Orthopedic Systems, Inc.

95 FDA decisions under this applicant name. See the company

  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996
  • K920256Spine Motion Analyzer with EmgOrthopedic Systems, Inc. · 1992
  • K910736Jackson Multipurpose Operating TableOrthopedic Systems, Inc. · 19911 recall
  • K910031Park City Shoulder PositionerOrthopedic Systems, Inc. · 1991
  • K903938C Fit CupOrthopedic Systems, Inc. · 1991

https://510kreport.com/device/K880253 · printed Nov 4, 2026

Cite this page

510(k) Report. “K880253: Blakemore Retainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880253

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