510(k) Report

510(k) · Cleared

Cleared

Shovel Retractor

K822109510(k) TraditionalCleared Jul 30, 198211-day reviewClass I21 CFR 888.1100

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

Bio-Blitz, Inc. · NBH Accessories, Arthroscopic

Cleared on Jul 30, 1982 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 30, 1982
Review
11 days
Class
Class I
Product code
NBH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822109Source: 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 NBH? 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 NBH devices

NBH Accessories, Arthroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NBH

FDA has decided no NBH device since 2007.

Median 510(k) review, days · NBH

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

Recalls per year · NBH

1in 2020

2009: 122010: 92012: 22013: 22015: 12016: 12020: 1
2007high 12 (2009) · low 0 (2007)2026

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

Adverse event reports per year · NBH

551in 2025

2007: 402008: 472009: 382010: 502011: 572012: 632013: 532014: 802015: 1852016: 3592017: 2242018: 3072019: 3582020: 3402021: 3892022: 3342023: 4922024: 6762025: 551
2007high 676 (2024) · low 38 (2009)2025

MAUDE reports naming product code NBH, 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—040
20080—047
20090—1238
20100—950
20110—057
20120—263
20130—253
20140—080
20150—1185
20160—1359
20170—0224
20180—0307
20190—0358
20200—1340
20210—0389
20220—0334
20230—0492
20240—0676
20250—0551
20260—0—

More from Bio-Blitz, Inc.

2 FDA decisions under this applicant name. See the company

  • K822108Cement-PickBio-Blitz, Inc. · 1982

Recent decisions in NBH

The NBH category page

  • K822560Irrigation SetUtah Medical Products, Inc. · 1982

https://510kreport.com/device/K822109 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822109: Shovel Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822109

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