# K972013: National Medical Healthcare Custom OB/Gyn Kits, Trays, or Packs

- Pathway: 510(k) (Traditional)
- Applicant: National Healthcare Mfg. Corp.
- Decided: Aug 26, 1997 after 88 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901442 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901442: Baxter D & C Tray, Baxter Healthcare Corp (1990) Summary page 2.

## Cited in the summary but kept off the family tree
- K912017: C-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.

## Indications for use
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

Source page: https://510kreport.com/device/K972013
Methodology: https://510kreport.com/methodology