510(k) Report

510(k) · Cleared

Cleared

National Medical Healthcare Custom OB/Gyn Kits, Trays, or Packs

K972013510(k) TraditionalCleared Aug 26, 199788-day reviewClass II21 CFR 884.4530

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

National Healthcare Mfg. Corp. · KNA Instrument, Manual, Specialized Obstetric-Gynecologic

Cleared on Aug 26, 1997 as substantially equivalent to K901442 (Baxter Healthcare Corp, 1990) after an 88-day review. Its family tree reaches back 1 generation to 1990.

Decided
Aug 26, 1997
Review
88 days
Class
Class II
Product code
KNA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K901442 (1990). No later device cites it as a predicate yet.

K901442 · Baxter D & C Tray · Baxter Healthcare Corp · 1990 · recalled19901992199419961998
K901442 · Baxter D & C Tray · Baxter Healthcare Corp · 1990 · recalled0
  1. Root · 1 generation backK901442 Baxter D & C TrayBaxter Healthcare Corp · 1990 · Recalled
  2. This deviceK972013 National Medical Healthcare Custom OB/Gyn Kits, Trays, or PacksNational Healthcare Mfg. Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901442Baxter D & C TrayBaxter Healthcare Corp19901
0 (this device)K972013National Medical Healthcare Custom OB/Gyn Kits, Trays, or PacksNational Healthcare Mfg. Corp.1997—
FIG. 1 — Lineage of K972013, 1990–1997Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KNA? 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
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K901442Baxter D & C Tray
Summary page 2
…: Custom medical convienance kits or trays are commonly available to medical professionals and institutions. Baxter received marketing clearance for a "D & C Tray" under K901442. Medical Device Inspection Co., Inc. received approval to market a C-Section Tray Under K912017/B. Comparative Information: The…
Baxter Healthcare Corp19901
Kept off the family treeK912017C-Section Tray
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…nstitutions. Baxter received marketing clearance for a "D & C Tray" under K901442. Medical Device Inspection Co., Inc. received approval to market a C-Section Tray Under K912017/B. Comparative Information: The subject device and the predicates are substantially identical in materials, packaging, steriliza…

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.

What does this lineage say?

  • Its one ancestor has a recall.

How does its category compare?

All KNA devices

KNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNA

1in 2014

2009: 12010: 12011: 12014: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNA

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

Recalls per year · KNA

No recall names KNA since 2007.

Adverse event reports per year · KNA

5in 2025

2007: 22010: 82011: 132012: 82013: 22014: 42015: 82016: 222017: 372018: 632019: 52021: 22022: 42023: 22024: 12025: 5
2007high 63 (2018) · low 0 (2008)2025

MAUDE reports naming product code KNA, 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—02
20080—00
20091—00
20101—08
20111—013
20120—08
20130—02
20141—04
20150—08
20160—022
20170—037
20180—063
20190—05
20200—00
20210—02
20220—04
20230—02
20240—01
20250—05
20260—0—

What is it indicated for?

This kits are a convenience assemblage of sterile, disposable medical devices intended for use by trained physicians for various gynocological and obstetrical procedures. See the attached list of "Obstetrical and Gynecological Devices". NHMC does not cause or promote new intended uses for the devices within these kits. Obstetrical and Gynecological Convenience Kits or Packs Amniocentesis Tray Breast Pump Kit Cervical Smear Kit Cesarean Section Tray…

Read the full statement (130 words)

This kits are a convenience assemblage of sterile, disposable medical devices intended for use by trained physicians for various gynocological and obstetrical procedures. See the attached list of "Obstetrical and Gynecological Devices".

NHMC does not cause or promote new intended uses for the devices within these kits.

Obstetrical and Gynecological Convenience Kits or Packs

Amniocentesis Tray

Breast Pump Kit

Cervical Smear Kit

Cesarean Section Tray

Circumcision Tray

Culdocentesis Kit

Cytology Kit

D and C Tray

Delivery Kit

Emergency Obstetrical Kit

Endometrial Sampling Kit

Fetal Blood Sampling Kit (Excludes HIV testing)

Forensic Evidence Sexual Assault Kit

Gynecological Laparoscopic Kit

Labor and Delivery Kit

Maternity Kit

Obstetrical Kit

Obstetrical Anesthesia Kit

Obstetrical Vacuum Delivery Kit

Pap Smear Kit

Paracervical Anesthesia Kit

Seminal Fluid Collection Kit

Trocar Kit

Vaginal Examination Tray

Vasovasostomy Set

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from National Healthcare Mfg. Corp.

7 FDA decisions under this applicant name. See the company

  • K971465National Medical Halthcare Custom Ophthalmic Kits or TraysNational Healthcare Mfg. Corp. · 1997
  • K971317National Medical Healthcare Custom Orthopedic Kits and TraysNational Healthcare Mfg. Corp. · 1997
  • K962670NHMC Irrigation TrayNational Healthcare Mfg. Corp. · 1996
  • K962254NHMC Urethral Catheterization TrayNational Healthcare Mfg. Corp. · 1996
  • K960523NHMC Dressing TrayNational Healthcare Mfg. Corp. · 1996

Recent decisions in KNA

The KNA category page

  • K130087Panpac Word/Bartholin CatheterPanpac Medical Corporation · 2014
  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006

https://510kreport.com/device/K972013 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972013: National Medical Healthcare Custom OB/Gyn Kits, Trays, or Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972013

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026