510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Todd Hewitt W/Cna (Lim Broth)

K871447510(k) TraditionalCleared May 13, 198730-day reviewClass I21 CFR 866.2360Recalls 1

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

Remel Co. · JSD Culture Media, Selective Broth

Cleared on May 13, 1987 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided
May 13, 1987
Review
30 days
Class
Class I
Product code
JSD
Recalls
1
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared1990200020102020
  1. This deviceK871447 Todd Hewitt W/Cna (Lim Broth)Remel Co. · 1987
  2. Descendant · cites it directly · 0 of its ownK170586 Strep B Carrot Broth One-StepHardy Diagnostics · 2017 · Recalled
  3. Descendant · cites it directly · 0 of its ownK170481 Strep B Carrot Broth KitHardy Diagnostics · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K170586Strep B Carrot Broth One-StepHardy Diagnostics · 2017 · cites it directly0descendants
  • K170481Strep B Carrot Broth KitHardy Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871447Todd Hewitt W/Cna (Lim Broth)Remel Co.1987—
+1K170586Strep B Carrot Broth One-StepHardy Diagnostics20172
+1K170481Strep B Carrot Broth KitHardy Diagnostics2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
FIG. 1 — Lineage of K871447, 1987–2017Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170586Strep B Carrot Broth One-StepHardy Diagnostics20170
K170481Strep B Carrot Broth KitHardy Diagnostics20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 14, 2023Class IIZ-2531-2023Under Investigation by firmOn lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K170586 (Hardy Diagnostics, 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JSD devices

JSD Culture Media, Selective Broth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSD

FDA has decided no JSD device since 2007.

Median 510(k) review, days · JSD

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

Recalls per year · JSD

No recall names JSD since 2007.

Adverse event reports per year · JSD

1in 2023

2012: 12021: 12022: 32023: 1
2007high 3 (2022) · low 0 (2007)2025

MAUDE reports naming product code JSD, 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—00
20080—00
20090—00
20100—00
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—03
20230—01
20240—00
20250—00
20260—0—

More from Remel Co.

137 FDA decisions under this applicant name. See the company

  • K013711Bacti-Swab DryRemel Co. · 2001
  • K965151A.C.T. IiiRemel Co. · 1997
  • K965149A.C.T. IRemel Co. · 1997
  • K965152A.C.T. IIRemel Co. · 19971 recall
  • K965150A.C.T. IVRemel Co. · 1997

Recent decisions in JSD

The JSD category page

  • K883075Fastidious Inoculum BrothBaxter Healthcare Corp · 1988
  • K880107Campy BrothHardy Media · 1988
  • K873324Sabouraud Dextrose (SD) Broth Tube, #T3331Lakewood Biochemical Co., Inc. · 1987
  • K873218Brain Heart Infusion Broth W/6.5% NAC1 - #T3802Lakewood Biochemical Co., Inc. · 1987
  • K871640Alkaline Peptone WaterBd Becton Dickinson Vacutainer Systems Preanalytic · 1987

https://510kreport.com/device/K871447 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871447: Todd Hewitt W/Cna (Lim Broth).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871447

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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